THE DRUGS AND COSMETICS ACT, 1940 
_____________ 

ARRANGEMENT OF SECTIONS  
_____________ 

CHAPTER I 

INTRODUCTORY 

SECTIONS 

1.   Short title, extent and commencement.  

2.   Application of other laws not barred.  

3.  Definitions. 

3A. Construction of references to any law not in force or any functionary not in  

existence in the State of Jammu and Kashmir.  

4.   Presumption as to poisonous substances.  

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE 

DRUGS CONSULTATIVE COMMITTEE 

5.   The Drugs Technical Advisory Board.  

6.   The Central Drugs Laboratory. 

7.   The Drugs Consultative Committee.  

7 A . Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs. 

CHAPTER III 

IMPORT OF DRUGS AND COSMETICS 

8.   Standards of quality. 

9.   Misbranded drugs. 

9A. Adulterated drugs. 

9B. Spurious drugs. 

9C. Misbranded cosmetics. 

9D. Spurious cosmetics. 

10. Prohibition of import of certain drugs or cosmetics.  

10A. Power of Central Government to prohibit import of drugs and cosmetics in  

      public interest. 

11. Application of law relating to sea customs and powers of Customs officers.  

12. Power of Central Government to make rules.  

13.  Offences. 

14.  Confiscation. 

15.  Jurisdiction.

1 

 
 
 
CHAPTER IV 

MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICS 

SECTIONS 

16.  Standards of quality. 
17.  Misbranded drugs. 
17A. Adulterated drugs. 
17B. Spurious drugs. 
17C. Misbranded cosmetics. 
17D. Spurious cosmetics. 
17E.  Adulterated cosmetics. 
18. Prohibition of manufacture and sale of certain drugs and cosmetics.  
18A. Disclosure of the name of the manufacturer, etc.  
18B. Maintenance of records and furnishing of information. 
19.  Pleas. 
20. Government Analysts. 
21.  Inspectors. 
22. Powers of Inspectors. 
23. Procedure of Inspectors. 
24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. 
25. Reports of Government Analysts. 
26. Purchaser of drug or cosmetic enabled to obtain test or analysis.  
26A. Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of                                  

drug and cosmetic in public interest. 

26B.  Powers of Central Government to regulate or restrict, manufacture, etc., of drug in 

public interest. 

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter. 
27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter. 
28. Penalty for non-disclosure of the name of the manufacturer , etc. 
28A.Penalty for not keeping documents, etc., and for non-disclosure of information. 
28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A. 
29. Penalty for use of Government Analyst ’s report for advertising. 
30. Penalty for subsequent offences. 
31. Confiscation.  
31A. Application of provisions to Government departments.  
32. Cognizance of offences. 
32A. Power of Court to implead the manufacturer, etc.  
32B. Compounding of certain offences.  
33. Power of Central Government to make rules.  
33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.  

CHAPTER IVA 
PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS 

33B. Application of Chapter IVA. 
33C. Ayurvedic and Unani Drugs Technical Advisory Board.  
33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.  

2 

 
 
 
SECTIONS 

33E.   Misbranded drugs. 

33EE. Adulterated drugs. 

33EEA.Spurious drugs. 

33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani  

drugs. 

33EEC.  Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani 

drugs. 

33EED.  Power of Central Government to prohibit manufacture, etc., of Ayurvedic, 

Siddha or Unani drugs in public interest. 

33F.  Government Analysts. 

33G.  Inspectors. 

33H.   Application of provisions of sections 22, 23, 24 and 25.  

33-I.   Penalty for manufacture, sale, etc., of Ayurvedic. Siddha or Unani  drug in 

contravention of this Chapter. 

33J.   Penalty for subsequent offences. 

33K.  Confiscation. 

33KA.  Disclosure of name of manufacturer, etc. 

33KB.  Maintenance of records and furnishing of informantion. 

33L.   Application of provisions to Government departments. 

33M. Cognizance of offences. 

33N.  Power of Central Government to make rules.  

33-O.  Power to amend First Schedule. 

CHAPTER V  

MISCELLANEOUS 

33P. Power to give directions. 

34. Offences by companies. 

34A. Offences by Government departments. 

34AA. Penalty for vexatious search or seizure. 

35. Publication of sentences passed under this Act.  

36. Magistrate’s power to impose enhanced penalties.  

36A. Certain offences to be tried summarily. 

36AB.  Special Courts. 

36AC. Offences to be cognizable and non-bailable in certain cases. 

36AD. Application of Code of Criminal Procedure, 1973 to proceedings before special Court. 

36AE. Appeal and revision. 

37.  Protection of action taken in good faith. 

38. Rules to be laid before Parliament. 

THE FIRST SCHEDULE. 
THE SECOND SCHEDULE.

3 

 
THE DRUGS AND COSMETICS ACT, 1940  

ACT NO. 23 OF 19401 

[10th April, 1940.] 

An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics]. 

WHEREAS it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs  2[and 

cosmetics]; 

AND WHEREAS the Legislatures of all the Provinces have passed resolutions in terms of section 103 
of  the  Government  of  India  Act,  1935  (26  Geo.  5,  c.  2),  in  relation  to  such  of  the  above-mentioned 
matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act: 

It is hereby enacted as follows: — 

CHAPTER I 

INTRODUCTORY 

1. Short title, extent and commencement. —(1) This Act may be called the Drugs 4[and Cosmetics] 

Act, 1940. 

(2) It extends to the whole of India 5*  *  *. 

(3) It shall come into force at once; but Chapter III shall take effect only from such date6 as the 

Central  Government  may,  by  notification  in  the  Official  Gazette,  appoint  in  this  behalf,  and            
Chapter IV shall take effect in a particular State only from such date6 as the State Government may, 
by like notification, appoint in this behalf : 

7[Provided that in relation to the State of Jammu and Kashmir*, Chapter III shall take effect only 
from  such  date8  after  the  commencement  of  the  Drugs  and  Cosmetics  (Amendment)  Act,  1972         
(19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this 
behalf.]

1.  The  Act  has  been  applied  to  all  the  partially  excluded  areas  in  the  State  of  Orissa,  see  Orissa  Government  notification           

No. 3358-LSG., dated the 25th August, 1941. 
2. Ins. by Act 21 of 1962, s.2 (w.e.f. 27-7-1964). 
3. Subs. by the A.O. 1950, for certain words.  
4. Ins. by Act 21 of 1962, s. 3 (w.e.f. 27-7-1964).  
5. The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, s. 2. 
6. 1st April, 1947; see notification No. F. 28(10) (3) 45H(I), dated the 2nd September, 1946, Gazette of India, 1946, Pt. I, p.  1349.  
     Ch. IV came into force in the States of Delhi. Ajmer and Coorg on the 1st April, 1947, see ibid., Chs. III and IV came into 
force  in  the  States  of  H.P.,  Bilaspur,  Kutch,  Bhopal,  Tripura,  Vindhya  Pradesh  and  Manipur  on  the  1st  April,  1953,  vide 
notification No. S.R.O. 663, dated the 30th March, 1953, Gazette of India, Pt II, Sec. 3, p. 451. 
the  Union 

    Ch.  IV  came 
see notification. No. ADM/Law/117(74), dated the 20th July, 1968, Gazette of India, PT. III, Sec. 3, p. 128. 
    The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s. 2 and Sch. I; to Pondicherry by Reg. 7 of 1963, s. 3 
and the Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and to the whole of the Union territory of Lakshadweep by 
Reg. 8 of 1965, s. 3 and Sch. 
7. Added by Act 19 of 1972, s. 2. 
8. 24th August, 1974, vide notification. No. S.O. 2185, dated the 9th August, 1974, Gazette of India, 1974, Pt. II, Sec. 3 (ii), p. 2331. 
 *. Vide Notification No. S.O. 3912 (E), dated 30th October, 2019, this Act is made applicable to the Union territory of Jammu 
and Kashmir and the Union territory of Ladakh. 

into  force 

in 

territory  of  Dadra  and  Nagar  Haveli  w.e.f.  1st  August,  1968,                                              

4 

 
 
                                                           
 
 
2. Application of other laws not barred. —The provisions of this Act shall be in addition 
to, and not in derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for 
the time being in force. 

3. Definitions. —In  this  Act,  unless  there  is  anything  repugnant  in  the  subject  or 

context, —  

1[(a)  “2[Ayurvedic,  Siddha  or  Unani]  drug”  includes  all  medicines  intended  for 
internal  or  external  use  for  or  in  the  diagnosis,  treatment,  mitigation  or  prevention  of 
3[disease  or  disorder  in  human  beings  or  animals,  and  manufactured]  exclusively  in 
accordance  with  the  formulae  described  in,  the  authoritative  books  of  3[Ayurvedic, 
Siddha and Unani Tibb system of medicine], specified in the First Schedule;]  

4[(aa) “the Board” means— 

(i)  in  relation  to  2[Ayurvedic,  Siddha  or  Unani]  drug,  the  3[Ayurvedic,  Siddha 

and Unani Drugs Technical Advisory Board] constituted under section 33C; and  

(ii)  in  relation  to  any  other  drug  or  cosmetic,  the  Drugs  Technical  Advisory  Board 

constituted under section 5;] 
5[ 6[(aaa)] “cosmetic” means any article intended to be rubbed, poured, sprinkled or 
sprayed  on,  or  introduced  into,  or  otherwise  applied  to,  the  human  body  or  any  part 
thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, 
and includes any article intended for use as a component of cosmetic  7* * *;]  

  8[(b) “drug” includes— 

9[(i) all medicines  for internal or external use of human beings or animals and all 
substances  intended  to  be  used  for  or  in  the  diagnosis,  treatment,  mitigation  or 
prevention  of  any  disease  or  disorder  in  human  beings  or  animals,  including 
preparations  applied  on  human  body  for  the  purpose  of  repelling  insects  like 
mosquitoes;] 

(ii)  such  substances  (other  than  food)  intended  to  affect  the  structure  or  any 
function of the human body or intended to be used for the destruction of  10[vermin] 
or  insects  which  cause  disease  in  human  beings  or  animals,  as  may  be  specified 
from  time  to  time  by  the  Central  Government  by  notification  in  the  Official 
Gazette;] 

11[(iii)  all substances intended for use as components of a drug including empty gelatin 

capsules; and 

(iv) such devices intended for internal or external use in the diagnosis, treatment, 
mitigation  or  prevention  of  disease  or  disorder  in  human  beings  or  animals,  as  may 
be  specified  from  time  to  time  by  the  Central  Government  by  notification  in  the 
Official Gazette, after consultation with the Board;] 

1. Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
2. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
3. Subs. by s. 3, ibid., for certain words (w.e.f. 1-2-1983). 
4. Clause (a) was re-lettered as cl. (aa) and subs. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
5. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 
6. Clause (aa) re-lettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
7. Certain words omitted by Act 68 of 1982, s.3 (w.e.f. 1-2-1983). 
8. Subs. by Act 11 of 1955, s. 2, for cl. (b). 
9. Subs. by Act 68 of 1982, s. 3, for sub-clause (i) (w.e.f. 1-2-1983). 
10. Subs. by Act 13 of 1964, s. 2 for “vermins” (w.e.f. 15-9-1964). 
11. Ins. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983). 

5 

 
                                                           
 1[(c) “Government Analyst” means—  

(i)  in  relation  to  2[Ayurvedic,  Siddha  or  Unani]  drug,  a  Government  Analyst 

appointed by the Central Government or a State Government under section 33F; and  

(ii)  in  relation  to  any  other  drug  or  cosmetic,  a  Government  Analyst  appointed  by  the  Central 

Government or a State Government under section 20;] 

 3*          

*   

  * 

* 

 * 

4[(e) “Inspector” means—  

(i)  in  relation  to  2[Ayurvedic,  Siddha  or  Unani]  drug,  an  Inspector  appointed  by 

the Central Government or a State Government  under section 33G; and 

(ii)  in  relation  to  any  other  drug  or  cosmetic,  an  Inspector  appointed  by  the 

Central Government or a State Government under section 21 ;] 

5[  6[(f)]  “manufacture”  in  relation  to  any  drug  7[or  cosmetic]  includes  any  process  or  part 
of  a  process  for  making,  altering,  ornamenting,  finishing,  packing,  labeling,  breaking  up  or 
otherwise treating or adopting any drug  7[or cosmetic] with a view to its  8[sale or distribution] but does 
not include the compounding or dispensing 9[of any drug, or the packing of any drug or cosmetic,] in the 
ordinary course of retail business; and “to manufacture” shall be construed accordingly;] 

10[(g)]  “to  import”,  with  its  grammatical  variations  and  cognate  expressions  means  to  bring  into 

11[India]; 

12[ 10[(h)] “patent or proprietary medicine” means, — 

 (i)  in  relation  to  Ayurvedic,  Siddha  or  Unani  Tibb  systems  of  medicine  all 
formulations  containing  only  such ingredients  mentioned  in  the  formulae  described  in the 
authoritative  books  of  Ayurvedic,  Siddha  or  Unani  Tibb  systems  of  medicine  specified  in 
the  First  Schedule,  but  does  not  include  a  medicine  wh ich  is  administered  by  parenteral 
route and also a formulation included in the authoritative books as specified in clause  (a); 

(ii)  in  relation  to  any  other  systems  of  medicine,  a  drug  which  is  a  remedy  or 
prescription  presented  in  a  form  ready  for  internal  or  external  administration  of  human 
beings or animals and which is not included in the edition of the Indian Pharmacopoeia 
for  the  time  being  or  any  other  Pharmacopoeia  authorised  in  this  behalf  by  the  Central 
Government  after  consultation  with  the  Drugs  Technical  Adivisory  Board  constituted 
under section 5;] 

13[  1 0[(i)] “prescribed” means prescribed by rules made under this Act.]   

1. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f. 15-9-1964). 
2. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).  
3. Cl. (d) omitted by Act 19 of 1972, s. 3. 
4. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964). 
5. Cl. (bbb) ins. by Act 11 of 1955, s. 2. 
6. Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961). 
7. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 
8. Subs. by Act 68 of 1982, s. 3, “sale and distribution” (w.e.f. 1-2-1983). 
9. Subs. by Act 21 of 1962, s. 4, for “or packing of any drug”. 
10. Cls. (c), (d) and (e) relettered as cls. (g), (h)  and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961). 
11. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.  
12. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983). 
13. Subs. by Act 11 of 1955, s. 2, for original cl. (e). 

6 

 
 
 
 
     
    
 
                                                           
1* 

* 

* 

* 

* 

2[3A. Construction of references to any law not in force or any functionary not in existence in 
the State of Jammu and Kashmir*.—Any reference in this Act to any law which is not in force, or any 
functionary  not  in  existence,  in  the  State  of  Jammu  and  Kashmir*,  shall,  in  relation  to  that  State,  be 
construed  as  a  reference  to  the  corresponding  law  in  force,  or  to  the  corresponding  functionary  in 
existence, in that State.] 

4.  Presumption  as  to  poisonous  substances.—Any  substance  specified  as  poisonous  by 
rule made under Chapter II or Chapter IV  3[or Chapter IVA] shall be deemed to be a poisonous 
substance for the purposes of Chapter III or Chapter IV 3[or Chapter IVA], as the case may be. 

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE 
DRUGS CONSULTATIVE COMMITTEE 

5. The Drugs Technical Advisory Board.—(1) The Central Government shall, as soon as may 
be,  constitute  a  Board  (to  be  called  the  Drugs  Technical  Advisory  Board)  to  advise  the  Central 
Government  and  the  State  Governments  on  technical  matters  arising  out  of  the  administration  of 
this Act and to carry out the other functions assigned to it by this Act. 

4[(2) The Board shall consist of the following members, namely :—  

(i) the Director General of Health Services,  ex officio, who shall be the Chairman; 

(ii) the Drugs Controller, India, ex officio; 

(iii) the Director of the Central Drugs Laboratory, Calcutta,  ex officio; 

(iv) the Director of the Central Research Institute, Kasauli,  ex officio; 

(v) the Director of the Indian Veterinary Research Institute, Izatnagar,  ex officio; 

(vi) the President of the Medical Council of India,  ex officio;  

(vii) the President of the Pharmacy Council of India,  ex officio; 

(viii) the Director of the Central Drug Research Institute, Lucknow,  ex officio; 

(ix)  two  persons  to  be  nominated  by  the  Central  Government  from  among  persons 

who are in charge of drugs control in the States;  

(x)  one  person,  to  be  elected  by  the  Executive  Committee  of  the  Pharmacy  Council  of 
India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on 
the staff of an Indian university or a college affiliated thereto;  

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from 
among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated 
thereto; 

(xii) one  person  to  be  nominated  by  the  Central  Governm ent  from  the  pharmaceutical 

industry; 

1. Cl. (f) omitted by Act 3 of 1951, s. 3 and Sch. 
2. Ins. by Act 19 of 1972, s. 4. 
3.  Ins. Act 13 of 1964, s. 3 (w.e.f. 15-9-1964).  
4. Subs. by s. 4, ibid., for sub-section (2) (w.e.f. 15-9-1964). 
*.  Vide Notification No. S.O. 3912 (E), dated 30th October, 2019, this Act is made applicable to the Union territory of Jammu 
and Kashmir and the Union territory of Ladakh. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of Medical 

Research; 

(xiv)  one  person  to  be  elected  by  the  Central  Council  of  the  Indian  Medical 

Association; 

(xv)  one  person  to  be  elected  by  the  Council  of  the  Indian  Pharmaceutical 

Association; 

(xvi)  two  persons  holding  the  appointment  of  Government  Analyst  under  this  Act,  to  be 

nominated by the Central Government.] 

(3) The nominated and elected members of the Board  shall hold office for three years, but shall be 

eligible for re-nomination and re-election : 

1[Provided  that  the  person  nominated  or  elected,  as  the  case  may  be,  under  clause  (ix)  or 
clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds 
the appointment of the office by virtue of which he was nominated or elected to the Board.]  

(4) The  Board  may,  subject  to  the  previous  approval  of  the  Central  Government,  make  bye -
laws  fixing  a  quorum  and  regulating  its  own  procedure  and  the  conduct  of  all  business  to  be 
transacted by it. 

(5) The Board may constitute sub-committees and  may appoint to such sub -committees for 
such periods, not exceeding three years, as it may decide , or temporarily for the consideration 
of particular matters, persons who are not members of the Board.  

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.  

(7) The Central Government shall appoint a person to be Secretary of the Board and shall 
provide  the  Board  with  such  clerical  and  other  staff  as  the  Central  Government  considers 
necessary. 

6.  The  Central  Drugs  Laboratory.—(1)  The  Central  Government  shall,  as  soon  as  may 
be,  establish  a  Central  Drugs  Laboratory  under  the  control  of  a  Director  to  be  appointed  by 
the  Central  Government,  to  carry  out  the  functions  entrusted  to  it  by  this  Act  or  any  rules 
made under this Chapter : 

Provided  that,  if  the  Central  Government  so  prescribes,  the  functions  of  the  Central  Drugs 
Laboratory in respect of any drug or class of drugs  2[or cosmetic or class of cosmetics] shall be 
carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and 
the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of 
drugs  2[or  such  cosmetic  or  class  of  cosmetics]  shall  be  exercised  by  the  Director  of  that 
Institute or of that other Laboratory, as the case may be. 

(2)  The  Central  Government  may,  after  consultation  with  the  Board,  make  rules 

prescribing—  

(a) the functions of the Central Drugs Laboratory ; 
3* 
* 
(d)  the  procedure  for  the  submission  to  the  said  Laboratory  4[under  Chapter  IV  or 
Chapter  IVA]  of  samples  of  drugs  2[or  cosmetics]  for  analysis  or  test,  the  forms  of  the 
Laboratory’s reports thereon and the fees payable in respect of such reports;  

                    * 

* 

* 

(e)  such other matters as may be necessary or expedient to enable the said Laboratory to carry 

out its functions; 

1. Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964). 
2. Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964). 
3. Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.  
4. Subs. by Act 13 of 1964, s. 5, for “under Chapter IV” (w.e.f. 15-9-1964). 

8 

 
 
 
 
 
 
 
 
 
                                                           
(f)    the  matters  necessary  to  be  prescribed  for  the  purposes  of  the  proviso  to 

sub-section (1). 

7.  The  Drugs  Consultative  Committee.—(1)  The  Central  Government  may  constitute  an 
advisory  committee  to  be  called  “the  Drugs  Consultative  Committee”  to  advise  the  Central 
Government,  the  State  Governments  and  the  Drugs  Technical  Advisory  Board  on  any  matter 
tending to secure uniformity throughout  1[India] in the administration of this Act. 

(2)  The  Drugs  Consultative  Committee  shall  consist  of  two  repr esentatives  of  the  Central 
Government  to  be  nominated  by  that  Government  and  one  representative  of  each  State 
Government to be nominated by the State Government concerned. 

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government 

and shall have power to regulate its own procedure. 

2[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.—Nothing contained        

in sections 5 and 7 shall apply to  3[Ayurvedic, Siddha or Unani] drugs.] 

CHAPTER III 

4[IMPORT OF DRUGS AND COSMETICS] 

8. Standards of quality.—5[(1) For the purposes of this Chapter, the expression  “standard quality” 

means—  

(a)  in  relation  to  a  drug,  that  the  drug  complies  with  the  standard  set  out  in  6[the  Second 

Schedule], and 

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.] 

(2) The Central Government, after consultation with the Board and after giving by notification 
in  the  Official  Gazette  not  less  than  three  months’  notice  of  its  intention  so  to  do,  may  by  a  like 
notification  add  to  or  otherwise  amend  6[the  Second  Schedule],  for  the  purposes  of  this  Chapter, 
and thereupon 6[the Second Schedule] shall be deemed to be amended accordingly. 

7[9.  Misbranded  drugs.—For  the  purposes  of  this  Chapter,  a  drug  shall  be  deemed  to  be 

misbranded— 

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to 

appear of better or greater therapeutic value than it really is; or 

(b) if it is not labelled in the prescribed manner; or  

(c) if its label or container or anything accompanying the drug bears any statement, design 
or  device  which  makes  any  false  claim  for  the  drug  or  which  is  false  or  misleading  in  any 
particular.] 

8[9A.  Adulterated  drugs.—For  the  purposes  of  this  Chapter,  a  drug  shall  be  deemed  to  be 

adulterated,—  

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or  

1. Subs. by Act 3 of 1951, s. 3 and the Sch., for “the States”. 
2. Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964). 
3. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
4. Subs. by s. 4, ibid., for the heading under Chapter III (w.e.f. 1-2-1983). 
5. Subs. by Act 21 of 1962, s. 2, for sub-section (1) (w.e.f. 27-7-1964). 
6. Subs. by Act 13 of 1964, s. 7, for “the Schedule” (w.e.f. 15-9-1964).  
7. Subs. by Act 68 of 1982, s. 5, for section 9 (w.e.f. 1-2-1983). 
8. Subs. by s. 6, ibid., for sections 9A and 9B (w.e.f. 1-2-1983). 

9 

 
                                                           
(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may 
have been contaminated with filth or whereby it may have been rendered injurious to health; 
or 

(c)  if  its  container  is  composed  in  whole  or  in  part,  of  any  poisonous  or  deleterious 

substance which may render the contents injurious  to health; or 

(d)  if  it  bears  or  contains,  for  purposes  of  colouring  only,  a  colour  other  than  one  which  is 

prescribed; or 

(e)  if  it  contains  any  harmful  or  toxic  substance  which  may  render  it  injurious  to 

health; or 

(f) if any substance has been mixed therewith so as to reduce its quality or strength.  

9B.  Spurious  drugs.—For  the  purposes  of  this  Chapter,  a  drug  shall  be  deemed  to  be 

spurious—  

(a) if it is imported under a name which belongs to another drug; or  

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in 
a manner likely to deceive or bears upon it or upon its label or container the name of another 
drug  unless  it  is  plainly  and  conspicuously  marked  so  as  to  reveal  its  true  c haracter  and  its 
lack of identity with such other drug; or 

(c) if  the  label  or  container  bears  the  name  of  an  individual  or  company  purporting  to 
be  the  manufacturer  of  the  drug,  which  individual  or  company  is  fictitious  or  does  not 
exist; or 

(d) if it has been substituted wholly or in part by another drug or substance; or  

(e) if it purports to be the product of a manufacturer of whom it is not truly a product  
9C.  Misbranded  cosmetics.—For the  purposes  of  this  Chapter,  a cosmetic shall  be  deemed  to  be 

misbranded— 

(a) if it contains a colour which is not prescribed; or  
(b) if it is not labelled in the prescribed manner; or  
(c)  if  the  label  or  container  or  anything  accompanying  the  cosmetic  bears  any 

statement which is false or misleading in any particular.  

9D.  Spurious  cosmetics.—For  the  purposes  of  this  Chapter,  a  cosmetic  shall  be  deemed  to  be 

spurious,—  

(a) if it is imported under a name which belongs to another cosmetic; or  

(b)  if  it is  an  imitation  of, or is  a substitute for,  another  cosmetic  or resembles  another 
cosmetic  in  a  manner  likely  to  deceive  or  bears  upon  it  or  upon  its  label  or  container  the 
name  of another  cosmetic,  unless it is plainly  and  conspicuously  marked so  as  to  reveal its 
true character and its lack of identity with such other cosmetic; or  

(c)  if the  label  ,or  container  bears  the  name  of  an  individual  or  a  company  purporting  to 
be  the  manufacturer  of  the  cosmetic  which  individual  or  company  is  fictitious  or  does  not 
exist; or 

(d) if it purports to be product of a manufacture of whom it is not truly a product.]  
10. Prohibition of import of certain drugs or cosmetics.—From such date1 as may be fixed 
by  the  Central  Government  by  notification  in the Official  Gazette  in this  behalf,  no  person  shall 
import— 

1. 1st April, 1947, for cls. (a), (b), (c), (e) and (f) and 1st April, 1949, for cl. (d), see notification No. 18-12-46-D-I, dated the 11th 
February, 1947, Gazette of India, 1947, Pt. I, p 189 as amended by notification No. F-1-2/48-D(I), dated the 29th September, 
1948, 1st April, 1953, for the State of H.P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur vide notification 
No. S.R.O. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 451.     

10 

 
 
 
                                                           
 (a) any drug  1[or cosmetic] which is not of standard quality;  

2[(b) any misbranded drug  3[or misbranded or spurious cosmetics] ;]  

4[(bb) any 5[adulterated or spurious;] drug;] 

(c) any drug  1[or cosmetic] for the import of which a licence is prescribed, otherwise 

than under, in accordance with, such licence;  

6[(d)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed 
manner on the label or container thereof  7[the true formula or list of active ingredients con -
tained in it together with the quantities thereof];] 

(e)  any  drug  which  by  means  of  any  statement,  design  or  device  accompanying  it  or 
by  any  other  means,  purports  or  claims  to  cure  or  mitigate  any  such  disease  or  ailment, 
or to have any such other effect, as may be prescribed;  

1[(ee)  any  cosmetic  containing  any  ingredient  which  may  render   it  unsafe  or 

harmful for use under the directions indicated or recommended;]  

(f)  any  drug  1[or  cosmetic]  the  import  of  which  is  prohibited  by  rule  made 

under this Chapter :  

Provided  that  nothing  in  this  section  shall  apply  to  the  import,  subject  to  prescribed  con-
ditions,  of  small  quantities  of  any  drug  for  the  purpose  of  examination,  test  or  ana lysis  or  for 
personal use : 

Provided  further  that  the  Central  Government  may,  after  consultation  with  the  Board,  by 
notification  in  the  Official  Gazette,  permit,  subject  to  any  conditions  specified  in  the 
notification, the import of any drug or class of drugs not being of standard quality.  

8* 

  * 

  * 

          * 

* 

9[10A.  Power  of  Central  Government  to  prohibit  import  of  drugs  and  cosmetics  in 
public  interest.—Without  prejudice  to  any  other  provision  contained  in  this  Chapter,  if  the 
Central  Government  is  satisfied  that  the  use  of  any  drug  or  cosmetic  is  likely  to  involve  any 
risk  to  human  beings  or  animals  or  that  any  drug  does  not  have  the  therapeutic  value  claimed 
for it or contains ingredients and in such quantity for which there is no therapeutic justification 
and that in the public interest it is necessary or expedient so to do then, that Government may, 
by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]  

11.  Application  of law relating to sea customs and  powers  of Customs officers. —(1) The 
law for the time being in force relating to sea customs and to goods, the import of which is  pro-
hibited by section 18 of the Sea Customs Act, 187810 (18 of 1878) shall, subject to the provisions 
of  section  13  of  this  Act,  apply  in  respect  of  drugs  11[and  cosmetics]  the  import  of  which  is       
prohibited under this Chapter and officers of Customs and officers empowered under that Act 
to perform the duties imposed thereby on a  12[Commissioner of Customs] and other officers of 

1. Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964). 
2. Subs. by s. 8, ibid., for clause (b) (w.e.f. 27-7-1964).  
3. Subs. by Act 68 of 1982, s. 7, for “or misbranded cosmetic” (w.e.f. 1 -2-1983). 
4. Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964). 
5. Subs, by Act 68 of 1982; s. 7, for “adulterated” (w.e.f. 1-2-1983). 
6. Subs. by Act 11 of 1955, s. 5, for clause (d). 
7. Subs. by Act 68 of 1982, s. 7, for certain words (w.e.f. 1-2-1983). 
8. The Explanation omitted by Act 68 of 1982, s. 7 (w.e.f. 1-2-1983). 
9. Ins. by s. 8, ibid. (w.e.f. 1-2-1983). 
10. Now see the Customs Act, 1962. 
11. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964). 
12. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”. 

11 

 
 
    
                                                           
Customs, shall have the same powers in respect of such drugs 1[and cosmetics] as they have for the time 
being in respect of such goods as aforesaid. 

2[(2)  Without  prejudice  to  the  provisions  of  sub -section  (1),  the  3[Commissioner  of      

Customs]  or  any  officer  of  the  Government  authorised   by  the  Central  Government  in  this 
behalf,  may  detain  any  imported  package  which  he  suspects  to  contain  any  drug  1[or 
cosmetic]  the  import  of  which  is  prohibited  under  this  Chapter  and  shall  forthwith  report 
such  detention  to  the  Drugs  Controller,  India  an d,  if  necessary,  forward  the  package  or 
sample of any suspected drug  1[or cosmetic] found therein to the Central Drugs Laboratory.]  

12.  Power  of  Central  Government  to  make  rules.  —(1)  The  Central  Government  may, 
4[after consultation with or on the recommendation of the Board] and after previous publication 
by  notification  in  the  Official  Gazette,  make  rules  for  the  purpose  of  giving  effect  to  the       
provisions of this Chapter : 

5[Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central     

Government  is  of  opinion  that  circumstances  have  arisen  which  render  it  necessary  to  make 
rules  without  such  consultation,  but  in  such  a  case  the  Board  shall  be  consulted  within  six 
months  of  the  making  of  the  rules  and  the  Central  Government  shall  take  into  consideration 
any suggestions which the Board may make in relation to the amendment of the said rules.]  

(2) Without prejudice to the generality of the foregoing power, such rules may —  

(a) specify the drugs or classes of drugs  6[or cosmetics or classes of cosmetics] for the 
import  of  which  a  licence  is  required,  7[and  prescribed  the  form  and  conditions  of  such 
licences, the authority empowered to issue the same, the fees payable therefor and provide 
for  the cancellation,  or  suspension  of such  licence  in  any  case  where  any  provision  of  this 
Chapter  or  the  rules  made  thereunder  is  contravened  or  any  of  the  conditions  subject  to 
which the licence is issued is not complied with] ;  

(b)  prescribe  the  methods  of  test  or  analysis  to  be  employed  in  determining  whether  a  drug        

6[or cosmetic] is of standard quality ; 

(c)  prescribe,  in  respect  of  biological  and  organometallic  compounds,  the  units  or  methods  of 

standardisation; 

8[(cc)  prescribe  under  clause  (d)  of  9[section  9A]  the  colour  or  colours  which  a  drug 

may bear or contain for purposes of colouring;]  

(d) specify the diseases or ailments which an imported drug may not purport or claim 
10[to prevent, cure or mitigate] and such other effects  which such drug may not purport or 
claim to have; 

(e) prescribe the conditions subject to which small quantities of drugs, the import of 
which  is  otherwise  prohibited  under  this  Chapter,  may  be  imported  for  the  purpose  of 
examination, test or analysis or for personal use; 

(f)  prescribe  the  places  at  which  drugs  6[or  cosmetics]  may  be  imported,  and  prohibited  their 

import at any other place; 

1. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964).  
2. Subs. by Act 11 of 1955, s. 6, for sub-section (2). 
3. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”. 
4. Subs. by Act 68 of 1982, s. 9, for “after consultation with the Board” (w.e.f. 1-2-1983). 
5. Ins. by Act 11 of 1955, s. 7. 
6. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964). 
7. Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983).  
8. Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964). 
9. Subs. by Act 68 of 1982, s. 9, for “section 9B” (w.e.f. 1-2-1983).  
10. Subs. by Act 11 of 1955, s. 7 for “to cure or mitigate”. 

12 

 
                                                           
(g)  require  the  date  of  manufacture  and  the  date  of  expiry  of  potency  to  be  clearly  and 
truely  stated  on  the  label  or  container  of  any  specified  imported  drug  or  class  of  such  drug, 
and prohibit the import of the said drug or class of drug after the expiry of a specified period 
from the date of manufacture; 

(h)  regulate  the  submission  by  importers,  and  the  securing,  of  samples  of  drugs           

1[or  cosmetics]  for  examination,  test  or  analysis  by  the  Central  Drugs  Laboratory,  and   
prescribed the fees, if any, payable for such examination, test or analysis;  

(i)  prescribe  the  evidence  to  be  supplied,  whether  by  accompanying  documents  or 
otherwise,  of  the  quality  of  drugs  1[or  cosmetics]  sought  to  be  imported,  the  procedure  of 
officers  of  Customs  in  dealing  with  such  evidence,  and  the  manner  of  storage  at  places  of  
import of drugs l[or cosmetics] detained pending admission; 

(j) provide for the exemption, conditionally or otherwise, from all or any of the pro visions 
of  this  Chapter  and  the  rules  made  thereunder  of  drugs  1[or  cosmetics]  imported  for  the 
purpose only of transport through, and export from,  2[India]; 

(k)  prescribe  the  conditions  to  be  observed  in  the  packing  in  bottles,  packages  or  other 
containers, of imported drugs  1[or cosmetics]  3[including the use of packing material which comes 
into direct contact with the drugs]; 

(l)  regulate  the  mode  of  labelling  drugs  1[or  cosmetics]  imported  for  sale  in  packages,  and 

prescribe the matters which shall or shall not be included in such labels; 

(m)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added 
to or contained in any imported drug, prohibit the import of any drug in which that proportion 
is exceeded, and specify substances which shall be deemed to be poisonous for the purposes 
of this Chapter and the rules made thereunder; 

(n)  require  that  the  accepted  scientific  name  of  any  specified  drug  shall  be  displayed  in  the 
prescribed  manner  on  the  label  or  wrapper  of  any  imported,  patent  or  proprietary  medicine 
containing such drug ; 

(o)  provide  for the  exemption, conditionally  or  otherwise, from  all or any  of  the  provisions  of 
this Chapter or the rules made thereunder of any specified drug or class of drugs  l[or cosmetics or 
class of cosmetics]. 

4[13. Offenees.—(1) Whoever himself or by any other person on his behalf imports,—  

(a) any  drug  deemed to be adulterated under section 9A or deemed to  be a  spurious drug 
under  section  9B  or  any  spurious  cosmetic  referred  to  in  section  9D  or  any  cosmetic  of  the 
nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term 
which may extend to three years and a fine which may extend to five thousand rupees;  

(b)  any  drug  or  cosmetic  other  than  a  drug  or  cosmetic  referred  to  in  clause  (a),  the 
import of which is prohibited under section 10, or any rule made under this Chapter, shall be 
punishable with imprisonment for a term which may extend to six months, or with fine which 
may extend to five hundred rupees, or with both; 

(c) any drug or cosmetic in contravention of the provisions of any notification issued under 
section  10A,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  three 
years, or with fine which may extend to five thousand rupees, or with both. 

1. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964). 
2. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”. 
3. Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).  
4. Subs. by s. 10, ibid., for section 13 (w.e.f. 1-2-1983). 

13 

 
                                                           
(2) Whoever having been convicted of an offence —  

(a)  under  clause  (a)  or  clause  (c)  of  sub-section  (1),  is  again  convicted  of  an  offence 
under  that  clause,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to 
five years, or with fine which may extend to ten thousand rupees, or with both; 

(b)  under  clause  (b)  of  sub-section  (1),  is  again  convicted  of  an  offence  under  that 
clause, shall be  punishable with imprisonment for a term  which  may extend to  one  year, 
or with fine which may extend to one thousand  rupees, or with both. 

(3) The punishment provided by this section shall be in addition to any penalty to which 

the offender may be liable under the provisions of section 11.]  

14.  Confiscation.—Where  any  offence  punishable  under  section  13  has  been  committed,  the 
consignment  of  the  drugs  1[or  cosmetics]  in  respect  of  which  the  offence  has  been  committed  shall  be 
liable to confiscation. 

15. Jurisdiction.—No Court inferior to that 2[of a Metropolitan Magistrate or of a Judicial Magistrate 

of the first class] shall try an offence punishable under section 13. 

CHAPTER IV 

MANUFACTURE, SALE AND DISTRIBUTION OF 3[DRUGS AND COSMETICS] 

16. Standards of quality. —4[(1) For the purposes of this Chapter, the expression “standard quality” 

means—  

(a)  in  relation  to  a  drug,  that  the  drug  complies  with  the  standard  set  out  in  5[the  Second 

Schedule], and 

(b) in  relation  to  a  cosmetic,  that  the  cosmetic  complies  with  such  stand ard  as  may 

be prescribed.] 
(2)  The  6[Central  Government],  after  consultation  with  the  Board  and  after  giving  by 
notification in the Official Gazette not less than three months ’ notice of its intention so to do, 
may by a like notification add to or otherwise amend  5[the Second Schedule] for the purposes 
of  this  Chapter,  and  thereupon  5[the  Second  Schedule]  shall  be  deemed  to  be  amended 
accordingly. 

7[17.  Misbranded  drugs.—For  the  purposes  of  this  Chapter,  a  drug  shall  be  deemed  to  be 

misbranded,—  

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it 

is made to appear of better or greater therapeutic value than it really is; or  

(b) if it is not labelled in the prescribed manner; or  

(c)  if  its  label  or  container  or  anything  accompanying  the  drug  bears  any  statement, 
design or device which makes any false claim for the drug or which is false or misleading in 
any particular. 

1. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964). 
2. Subs. by Act 68 of 1982, s. 11, for certain words (w.e.f. 1-2-1983). 
3. Subs. by s. 12, ibid., for “DRUGS” (w.e.f. 1-2-1983). 
4. Subs. by Act 21 of 1962, s. 12, for sub-section (1) (w.e.f. 27-7-1964). 
5. Subs. by Act 13 of 1964, s. 11, for “the Schedule” (w.e.f. 15-9-1964). 
6. Subs. by Act 11 of 1955, s. 8, for “State Government”. 
7. Subs. by Act 68 of 1982, s. 13, for sections 17, 17A and 17B (w.e.f. 1-2-1983).  

14 

 
 
                                                           
17A.  Adulterated  drugs.—  For  the  purposes  of  this  Chapter,  a  drug  shall  be  deemed  to  be 

adulterated,— 

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance;  or 

(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it 
may have been contaminated with filth or whereby it may have been rendered injurious to 
health; or 

(c)  if  its  container  is  composed,  in  whole  or  in  part,  of  any  poisonous  or  deleterious 

substance which may render the contents injurious to health; or  

(d)  if  it  bears  or  contains,  for  purposes  of  colouring  only,  a  colour  other  than  one  which  is 

prescribed; or 

(e)  if  it  contains  any  harmful  or  toxic  substance  which  may  render  it  injurious  to 

health; or 

(f) if any substance has been mixed therewith so as to reduce its quality or strength.  

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be 

spurious,—  

(a) if it is manufactured under a name which belongs to another drug; or 

(b) if it is an  imitation of,  or is  a substitute for, another drug  or resembles  another  drug 
in  a  manner  likely  to  deceive  or  bears  upon  it  or  upon  its  label  or  container  the  name  of 
another drug unless it is plainly and conspicuously marked so as to reveal its  true character 
and its lack of identity with such other drug; or 

(c)  if  the  label  or  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the drug, which individual or company is fictitious or does not exist; or 

(d) if it has been substituted wholly or in part by another drug or substance; or 

(e) if it purports to be the product of a manufacturer of whom it is not truly a product. 

17C. Misbranded cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be 

misbranded,—  

(a) if it contains a colour which is not prescribed; or 

(b) if it is not labelled in the prescribed manner; or 

(c) if the label or container or anything accompanying the cosmetic  bears any state-

ment which is false or misleading in any particular.  

17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be 

spurious,—  

(a) if it is manufactured under a name which belongs to another cosmetic; or 

(b) if  it  is  an  imitation  of,  or  a  substitute  for,  another  cosmetic  or  resembles  another 
cosmetic  in  a  manner likely  to  deceive  or  bears  upon  it  or  upon its  label  or container  the 
name of another cosmetic unless it is plainly and conspicuously marked so as to re veal its 
true character and its lack of identity with such other cosmetic; or  

(c)  if  the  label  or  container  bears  the  name  of  an  individual  or  a  company  purporting  to 
be  the  manufacturer  of  the  cosmetic  which  individual  or  company  is  fictitious  or  does  not  
exist; or 

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.] 

15 

 
1[17E. Adulterated cosmetics. — For the purposes of this Chapter, a cosmetic shall be deemed to be 

adulterated,— 

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or 
(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may  have 

been contaminated with filth or whereby it may have been rendered injurious to health; or 

(c)  if its container is composed, in whole or in part, of any poisonous or deleterious substance 

which may render the contents injurious to health; or 

(d)  if  it  bears  or  contains,  for  purposes  of  colouring  only,  a  colour  other  than  one  which  is 

prescribed; or 

(e) if it contains any harmful or toxic substance which may render it injurious to health; or 
(f) if any substance has been mixed therewith so as to reduce its quality or strength.] 

18.  Prohibition  of  manufacture  and  sale  of  certain  drugs  and  cosmetics.—From  such  2date  as 
may  be  fixed  by  the  State Government  by  notification  in  the  Official  Gazette  in  this  behalf,  no  person 
shall himself or by any other person on his behalf—  

(a)  3[manufacture  for  sale  or  for  distribution,  or  sell,  or  stock  or  exhibit  or  offer  for  sale,]  or 

distribute—  

4[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; 
5[(ii)  any  cosmetic  which  is  not  of  a  standard  quality  or  is  misbranded,  adulterated  or 

spurious;]] 

6[(iii) any patent or proprietary medicine, unless there is displayed in the pres cribed 
manner  on  the  label  or  container  thereof  3[the  true  formula  or  list  of  active  ingredients 
contained in it together with the quantities thereof];]  

(iv)  any  drug  which  by  means  of  any  statement  design  or  device  accompanying  it  or 
by any other means, purports or claims  7[to prevent, cure or mitigate] any such disease or 
ailment, or to have any such other effect as may be prescribed; 

8[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use 

under the directions indicated or recommended; 

(vi)  any  drug  or  cosmetic in  contravention  of  any  of the  provisions  of  this  Chapter or  any 

rule made thereunder;] 
(b) 3[sell or stock or exhibit or offer for sale,] or distribute any drug 9[or cosmetic] which has been 
imported  or  manufacutred  in  contravention  of  any  of  the  provisions  of  this  Act  or  any  rule  made 
thereunder; 

(c) 3[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] 
or  distribute  any  drug  9[or  cosmetic],  except  under,  and  in  accordance  with  the  conditions 
of, a licence issued for such purpose under this Chapter:  
Provided  that  nothing  in  this  section  shall  apply  to  the  manufacture,  subject  to  prescribed 

conditions, of small quantities of any drug for the purpose of examination, test or analysis :  

Provided  further  that  the  10[Central  Government]  may,  after  consultation  with  the  Board,  by 
notification in the Official Gazette, permit, subject to any conditions specified in the notifica tion, 
the  11[manufacture for sale or for distribution, sale, stocking or exhibiting o r offering for sale] or 
distribution of any drug or class of drugs not being of standard quality. 

1. Ins. by Act 26 of 2008, s. 2 (w.e.f. 10-8-2009).  
2.  1st  April,  1947  for  sub-clauses  (i),  (ii),  (iv)  and  (v)  of  cl.  (a)  and  cls.  (b)  and  (c);  1st  April,  1949  for  sub-clause  (iii)  of  
cl. (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notifn. No. 18-12-46-D, II, dated 11th February, 1947, Gazette of 
India, 1947, Pt. I, p. 189, as amended by notifn. No. F. 1-2/48-D (ii), dated 29th September, 1948; 1st April, 1953  for the States of    
H.  P.,  Bilaspur,  Kutch,  Bhopal,  Tripura,  Vindhya  Pradesh  and  Manipur,  vide  notifn.  No.  S.R.O.  664,  dated  the  30th  March,  1953, 
Gazette of India, 1953, Pt. II, Sec. 3, p. 451  

3. Subs. by Act 68 of 1982. s. 14, for certain words (w.e.f. 1-2-1983). 
4. Subs. by s. 14, ibid, for cls. (i), (ii) and (iia) (w.e.f. 1-2-1983). 
5. Subs. by Act 26 of 2008, s. 3, for sub-clause (ii) (w.e.f.10-8-2009). 
6. Subs. by Act 11 of 1955, s. 9, for sub-clause (iii). 
7. Subs by s. 9, ibid., for “to cure or mitigate”. 
8. Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964). 
9. Ins. by s. 14, ibid. (w.e.f. 27-7-1964). 
10. Subs. by Act 11 of 1955, s. 9, for “State Government”. 
11. Subs. by Act 68 of 1982, s. 14, for “manufacture for sale, sale” (w.e.f. 1-2-1983).  

16 

 
                                                           
1* 

* 

            * 

*   

               * 

2[18A.  Disclosure  of  the  name  of  the  manufacturer,  etc.—Every  person,  not  being  the 
manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose 
to the Inspector the name, address and other particulars of the person from whom he acquired the drug or 
cosmetic.] 

3[18B.  Maintenance  of  records  and  furnishing  of  information.—Every  person  holding  a 
licence  under  clause  (c)  of  section  18  shall  keep  and  maintain  such  records,  registers  and  other 
documents  as  may  be  prescribed  and  shall  furnish  to  any  officer  or  authority  exercising  any 
power or discharging any function under this Act such information as is required by such officer 
or authority for carrying out the purposes of this Act.]  

19.  Pleas.—(1)  Save  as  hereinafter  provided  in  this  section,  it  shall  be  no  defence  in  a  pro -
secution under this Chapter to prove  merely that the accused was ignorant of the nature, substance 
or quality of the drug  4[or cosmetic] in respect of which the offence has been committed or of the 
circumstances of its manufacture or import, or that a purchaser, having bought only for the pu rpose 
of test or analysis, has not been prejudiced by the sale. 

(2)  5[For  the  purposes  of  section  18  a  drug  shall  not  be  deemed  to  be  misbranded  or 
6[adulterated or spurious] or to be below standard quality nor shall a cosmetic be deemed to be 
misbranded or to be below standard quality] only by reason of the fact that —  

(a)  there  has  been  added  thereto  some  innocuous  substance  or  ingredient  because  the 
same  is required  for  the manufacture  or  preparation  of the  drug  4[or  cosmetic] as  an  article 
of commerce  in a state fit for carriage or consumption, and not to increase the bulk, weight 
or measure of the drug  4[or cosmetic] or to conceal its inferior quality or other defects; or  

7* 

       *  

              * 

                      * 

                                  * 

(b) in the process of  manufacture, preparation or conveyance some extraneous sub stance 
has  unavoidably  become  intermixed  with  it:  provided  that  this  clause  shall  not  apply  in 
relation  to  any  sale  or  distribution  of  the  drug  4[or  cosmetic]  occurring  after  the  vendor  or 
distributor became aware of such intermixture. 

8[(3)  A  person,  not  being  the  manufacturer  of  a  drug  or  cosmetic  or  his  agent  for  the  distribution 

thereof, shall not be liable for a contravention of section 18 if he proves—  

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer 

thereof; 

(b) that  he  did  not  know  and  could  not,  with  reasonable  diligence,  have  ascertained  that 

the drug or cosmetic in any way contravened the provisions of that section; and  

(c)  that  the  drug  or  cosmetic,  while  in  his  possession,  was  properly  stored  and 

remained in the same state as when he acquired it.]  

1. The Explanation omitted by Act 68 of 1982, s. 14 (w.e.f. 1-2-1983). 
2. Ins. by Act 13 of 1964, s. 14 (w.e.f. 15-9-1964). 
3. Ins. by Act 68 of 1982, s. 15 (w.e.f. 1-2-1983). 
4. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964). 
5. Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964).   
6. Subs. by Act 68 of 1982, s. 16, for “adulterated” (w.e.f. 1-2-1983). 
7. Cl. (aa) ins. by Act 11 of 1955, s. 10, omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964). 
8. Subs. by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964). 

17 

 
 
                                                           
1[20.  Government  Analysts.—(1)  The  State  Government  may,  by  notification  in  the 
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be 
Government  Analysts  for  such  areas  in  the  State  and  in  respect  of  such  dru gs  or  2[classes  of 
drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.  

(2) The Central Government may also, by notification in the Official Gazette, appoint such 
persons  as  it  thinks  fit,  having  the  prescribed  qualific ations,  to  be  Government  Analysts  in     
respect of such drugs or  2[classes of drugs or such cosmetics or classes of cosmetics] as may be 
specified in the notification. 

(3)  Notwithstanding  anything  contained  in  sub-section  (1)  or  sub-section  (2),  neither  the  
Central  Government  nor  a  State  Government  shall  appoint  as  a  Government  Analyst  any      
official  not  serving  under  it  without  the  previous  consent  of  the  Government  under  which  he 
is serving. 

3[(4)  No  person  who  has  any  financial  interest  in  the  import,  manufacture  or  sale  of  drugs                   

or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of 
this section.] 

21.  Inspectors.—(1)  The  Central  Government  or  a  State  Government  may,  by 
notification  in  the  Official  Gazette,  appoint  such  persons  as  it  thinks  fit,  having  the 
prescribed  qualifications, to  be  Inspectors for such areas as  may be assigned to them by the 
Central Government or the State Government, as the case may be.  

(2)  The  powers  which  may  be  exercised  by  an  Inspector  and  the  duties  which  may  be      

performed  by  him,  the  drugs  or  4[classes  of  drugs  or  cosmetics  or  classes  of  cosmetics]  in 
relation to which and the conditions, limitations or restrictions subject to which, such  powers 
and duties may be exercised or performed shall be such as may be prescribed.  

(3)  No  person  who  has  any  financial  interest  5[in  the  import,  manufacture  or  sale  of  drugs  or 

cosmetics] shall be appointed to be an Inspector under this section. 

(4)  Every  Inspector  shall  be  deemed  to  be  a  public  servant  within  the  meaning  of      

section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such 
authority  6[having  the  prescribed  qualifications,]  as  the  Government  appointing  him  may 
specify in this behalf.] 

7[22. Powers of Inspectors.—(1) Subject to the provisions of section 23 and of any rules 
made  by  the  Central  Government  in  this  behalf,  an  Inspector  may,  within  the  local  limits  of 
the area for which he is appointed,— 

8 [(a) inspect,—  

(i) any premises  wherein any drug or cosmetic is being manufactured and the 

means employed for standardising and testing the drug or cosmetic;  

(ii)  any  premises  wherein  any  drug  or  cosmetic  is  being  sold,  or  stocked  or 

exhibited or offered for sale, or distributed;  

1. Subs by Act 35 of 1960, s. 4, for the original sections 20 and 21 (w.e.f. 16-3-1961).  
2. Subs. by Act 21 of 1962, s. 16, for “class of drugs” (w.e.f. 27-7-1964). 
3. Ins. by Act 68 of 1982, s. 17 (w.e.f. 1-2-1983).  
4. Subs. by Act 21 of 1962, s. 17, for “class of drugs” (w.e.f. 27-7-1964). 
5. Subs. by s. 17, ibid., for “in the manufacture, import or sale of drugs” (w.e.f. 27-7-1964).  
6. Ins. by Act 68 of 1982, s. 18 (w.e.f. 1-2-1983). 
7. Subs. by Act 11 of 1955, s. 11, for s. 22. 
8. Subs. by Act 68 of 1982, s. 19, for cls. (a), (b) and (c) (w.e.f. 1-2-1983). 

18 

 
                                                           
(b) take samples of any drug or cosmetic,  — 

(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, 

or is being distributed; 

(ii) from any person who is in the course of conveying, delivering or preparing to 

deliver such drug or cosmetic to a purchaser or a consignee;  

(c)  at  all  reasonable  times,  with  such  assistance,  if  any,  as  he  considers 

necessary,—  

(i)  search  any  person,  who,  he  has  reason  to  believe,  has  secreted  about  his  person, 
any  drug  or  cosmetic  in  respect  of  which  an  offence  under  this  Chapter  has  been,  or  i s 
being, committed; or 

(ii)  enter  and  search  any  place  in  which  he  has  reason  to  believe  that  an  offence 

under this Chapter has been, or is being, committed; or  

(iii) stop and search any vehicle, vessel or other conveyance which, he has reason 
to  believe,  is  being  used  for  carrying  any  drug  or  cosmetic  in  respect  of  which  an 
offence under this Chapter has been, or is being, committed,  

and  order in  writing the  person  in  possession of  the  drug  or cosmetic in  respect  of  which  the 
offence has been, or is being, committed, not to dispose of any stock of such drug or cosmetic 
for  a  specified  period  not  exceeding  twenty  days,  or,  unless  the  alleged  offence  is  such  that 
the  defect  may  be  removed  by  the  possessor  of  the  drug  or  cosmetic,  seize  the  stock  of  such 
drug  or  cosmetic  and  any  substance  or  article  by  means  of  which  the  offence  has  been,  or  is 
being, committed or which may be employed for the commission of such offence;]  

1[(cc)  examine  any  record,  register,  document  or  any  other  material  object  found  2[with 
any  person,  or  in  any  place,  vehicle,  vessel  or  other  conveyance  referred  to  in  clause  ( c)], 
and  seize  the  same  if  he  has  reason  to  believe  that  it  may  furnish  evidence  of  the 
commission of an offence punishable under this Act or the rules made thereunder;]  

3[(cca)  require  any  person  to  produce  any  record,  register,  or  other  document  relating 
to the  manufacture for sale  or for distribution, stocking,  exhibition for sale, offer for sale 
or distribution of any drug or cosmetic in respect of which he has reason  to believe that an 
offence under this Chapter has been, or is being, committed;]  

(d) exercise such other powers as may be necessary for carrying out the purposes of 

this Chapter or any rules made thereunder.  

(2) The provisions of  4[the Code of Criminal Procedure, 1973 (2 of 1974)] shall, so far as 
may  be,  apply  to  any  search  or  seizure  under  this  Chapter  as  they  apply  to  any  search  or 
seizure made under the authority of a warrant issued under  5[section 94] of the said Code. 

3[(2A) Every record, register or other document seized under clause  (cc)  or produced under       

clause (cca) shall be returned to the person, from whom they were seized or who produce the 

1. Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961). 
2. Subs. by Act 68 of 1982, s. 19, for certain words (w.e.f. 1-2-1983). 
3. Ins. by s. 19, ibid. (w.e.f. 1-2-1983). 
4. Subs. by s. 19, ibid., for “the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983). 
5. Subs. by s. 19, ibid., for “section 98” (w.e.f. 1-2-1983). 

19 

 
                                                           
same, within a period of twenty days of the date of such seizure or produ ction, as the case may 
be,  after  copies  thereof  or  extracts  therefrom  certified  by  that  person,  in  such  manner  as  may  be  
prescribed, have been taken.] 

(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred 
upon  him  by  or  under  this  Chapter  1[or  refuses  to  produce  any  record,  register  or  other 
document  when  so  required  under  clause  (cca)  of  sub-section  (1),]  he  shall  be  punishable 
with imprisonment which may extend to three years, or with fine, or with both.]  

23.  Procedure  of  Inspectors.—(1)  Where  an  Inspector  takes  any  sample  of  a  drug  2[or      

cosmetic]  under  this  Chapter,  he  shall  tender  the  fair  price  thereof  and  may  require  a  written 
acknowledgment therefor. 

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes 
the  stock  of  any  drug  2[or  cosmetic]  under  clause  (c)  of  section  22,  he  shall  tender  a  receipt 
therefor in the prescribed form. 

(3)  Where  an  Inspector  takes  a  sample  of  a  drug  2[or  cosmetic]  for  the  purpose  of  test  or 
analysis,  he  shall  intimate  such  purpose  in  writing  in  the  prescribed  form  to  the  person  from 
whom  he  takes  it  and,  in  the  presence  of  such  person  unless  he  wilfully  abse nts  himself,  shall 
divide the sample into four portions and effectively seal and suitably mark the same and permit 
such person to add his own seal and mark to all or any of the portions so sealed and marked:  

Provided  that  where  the  sample  is  taken  from  pre mises  whereon  the  drug  2[or  cosmetic] 

is being manufactured, it shall be necessary to divide the sample into three portions only:  

Provided  further  that  where  the  drug  2[or  cosmetic]  is  made  up  in  containers  of  small 
volume,  instead  of  dividing  a  sample  as  aforesaid,  the  Inspector  may,  and  if  the  drug  2[or 
cosmetic]  be  such  that  it  is  likely  to  deteriorate  or  be  otherwise  damaged  by  exposure  shall, 
take three or four, as the case may be, of the said containers after suitably marking the same 
and, where necessary, sealing them. 

(4)  The  Inspector  shall  restore  one  portion  of  a  sample  so  divided  or  one  container,  as  the 
case may be, to the person from whom he takes it, and shall retain the remainder and dispose of 
the same as follows:— 

(i) one portion or container he shall forthwith send to the Government Analyst for test 

or analysis; 

(ii) the second, he shall produce to the Court before which proceedings, if any, are 

instituted in respect of the drug  2[or cosmetic]; and 

3[(iii) the third, where taken, he shall send to the person, if any, whose name, address 

and other particulars have been disclosed under section 18A. ] 

(5) Where an Inspector takes any action under clause  (c) of section 22,— 

(a)  he  shall  use  all  despatch  in  ascertaining  whether  or  not  the  drug  2[or  cosmetic]; 
contravenes any of the provisions of section 18 and, if it is ascertained that the drug  2[or 
cosmetic];  does  not  so  contravene,  forthwith  revoke  the  order  passed  under  the  said 
clause or, as the case  may  be, take such action  as  may be necessary for the return of the 
stock seized; 

(b) if he seizes the stock of the drug 2[or cosmetic]; he shall as soon as may be inform 4[a Judicial 

Magistrate] and take his orders as to the custody thereof; 

1. Ins. by Act 68 of 1982, s. 19 (w.e.f. 1-2-1983). 
2. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).  
3. Subs. by Act 13 of 1964, s. 16, for cl. (iii) (w.e.f. 15-9-1964). 
4. Subs. by Act 68 of 1982, s. 20, for “a Magistrate” (w.e.f. 1-2-1983).  

20 

 
                                                           
( c ) without  prejudice to  the  institution  of  any  prosecution,  if the  alleged  contravention  be  such 
that  the  defect  may  be  remedied  by  the  possessor  of  the  drug  1[or  cosmetic];  he  shall,  on  being 
satisfied that the defect has been so remedied, forthwith revoke his order under the said clause. 

2[(6)  Where  an  Inspector  seizes  any  record,  register,  document  or  any  other  material  object  under 
clause (cc) of sub-section (1) of section 22, he shall, as soon as may be, inform  3[a Judicial Magistrate] 
and take his orders as to the custody thereof. 

24.  Persons  bound  to  disclose  place  where  drugs  or  cosmetics  are  manufactured  or  kept.  —
Every  person  for  the  time  being  in  charge  of  any  premises  whereon  any  drug  1[or 
cosmetic]; is being manufactured or is kept for sale or distribution shall, on being required 
by  an  Inspector  so  to  do,  be  legally  bound  to disclose  to  the  Inspector  the  place  where  the 
drug  1[or cosmetic] is being manufactured or is kept, as the case  may be. 

25.  Reports  of  Government  Analysts. —(1)  The  Government  Analyst  to  whom  a 

sample  of  any  drug  1[or  cosmetic]  has  been  submitted  for  test  or  analysis  under             
sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed  report in 
triplicate in the prescribed form.  

(2)  The  Inspector  on  receipt  thereof  shall  deliver  one  copy  of  the  report  to  the  person 
from  whom  the  sample  was  taken  4[and  another  copy  to  the  person,  if  any,  whose  name, 
address  and  other  particulars  have  been  disclosed  under  section  18A],  and  shall  retain  the 
third copy for use in any prosecution in respect of the sample.  

(3)  Any  document  purporting  to  be  a  report  signed  by  a  Government  Analyst  under  this 
Chapter  shall  be  evidence  of  the  facts  stated  therein,  and  such  evidence  shall  be  conclusive 
unless  the  person  from  whom  the  sample  was  taken  5[or  the  person  whose  name,  address  and 
other  particulars  have  been  disclosed  under  section  18A]  has,  within  twenty -eight  days  of  the 
receipt of a copy of the report, notified in writing the Inspector or the Court before which any 
proceedings  in  respect  of  the  sample  are  pending  that  he  intends  to  adduce  evidence  in         
controversion of the report. 

(4)  Unless the sample has already been tested or analysed in the Central Drugs Laboratory, 
where  a  person  has  under  sub-section  (3)  notified  his  intention  of  adducing  evidence  in         
controversion  of  a  Government  Analyst’s  report,  the  Court  may,  of  its  own  motion  or  in  its 
discretion  at  the  request  either  of  the  complainant  or  the  accused  cause  the  sample  of  the  drug          
1[or cosmetic] produced before the Magistrate under sub -section (4) of section 23 to be sent for 
test  or  analysis  to  the  said  Laboratory,  which  shall  make  the  test  or  analysis  and  report  in 
writing  signed  by  or  under  the  authority  of,  the  Director  of  the  Ce ntral  Drugs  Laboratory  the 
result thereof, and such report shall be conclusive evidence of the facts stated therein.  

(5)  The  cost  of  a  test  or  analysis  made  by  the  Central  Drugs  Laboratory  under                

sub-section (4) shall be paid by the complainant or accused as the Court shall direct . 

26.  Purchaser  of  drug  or  cosmetic  enabled  to  obtain  test  or  analysis .—Any  person      

6[or any recognised consumer association, whether such person is a member of that association 
or not,] shall, on application in the prescribed manner and on payment of the prescribed fee, be 
entitled  to  submit  for  test  or  analysis  to  a  Government  Analyst  any  drug  1[or  cosmetic] 
7[purchased  by  him  or  it]  and  to  receive  a  report  of  such  test  or  analysis  signed  by  the 
Government Analyst.     

1. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964). 
2. Ins. by Act 35 of 1960, s. 6 (w.e.f. 16-3-1961). 
3. Subs. by Act 68 of 1982, s. 20, for “a Magistrate” (w.e.f. 1-2-1983). 
4. Subs. by Act 13 of 1964, s. 17, for certain words (w.e.f. 15-9-1964). 
5. Subs. by s. 17, ibid., for “or the said warrantor” (w.e.f. 15-9-1964). 
6. Ins. by Act 71 of 1986, s. 2 (w.e.f. 15-9-1987). 
7. Subs. by s. 2, ibid., for “purchased by him” (w.e.f. 15-9-1987). 

21 

 
                                                           
1[Explanation.—For the purposes of this section and section 32, “recognised consumer association 
means a voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any 
other law for the time being in force.] 

2[26A.  Powers  of  Central  Government  to  3[regulate,  restrict  or  prohibit]  manufacture,  etc., 
of drug and cosmetic in public interest.—Without prejudice to any other provision contained in this 
Chapter,  if  the  Central  Government  is  satisfied,  that  the  use  of  any  drug  or  cosmetic  is  likely  to 
involve  any  risk  to  human  beings  or  animals  or  that  any  drug  does  not  have  the  therapeutic  value 
claimed or purported to be claimed for it or contains ingredients and in such quantity for which there 
is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, 
that  Government  may,  by  notification  in  the  Official  Gazette,  3[regulate,  restrict  or  prohibit]  the 
manufacture, sale or distribution of such drug or cosmetic.] 

4[26B.  Power  of  Central  Government  to  regulate  or  restrict,  manufacture,  etc.,  of  drug  in 
public  interest.  —Without  prejudice  to  any  other  provision  contained  in  this  Chapter,  if  the  Central 
Government is satisfied that a drug is essential to meet the requirements of an emergency arising due to 
epidemic or natural calamities and that in the public interest, it is necessary or expedient so to do, then, 
that Government may, by notification in the Official Gazette, regulate or restrict the manufacture, sale or 
distribution of such drug.] 
5[27.  Penalty 

for  manufacture, 

contravention  of 

etc.,  of  drugs 

sale, 

in 

this                                

Chapter.—Whoever,  himself  or  by  any  other  person  on  his  behalf,  manufactures  for  sale  or  for 
distribution, or sells, or stocks or exhibits or offers for sale or distributes,—  

(a)  any  drug  deemed to  be adulterated under  section 17A  or  spurious  under  section  6[17B 
and  which]  when  used  by  any  person  for  or  in  the  diagnosis,  treatment,  mitigation,  or  pre -
vention of any disease or disorder is likely to cause his death or is likely to cause such harm on 
his  body  as  would  amount  to  grevious  hurt  within  the  meaning  of  section  320  o f  the  Indian 
Penal Code (45 of 1860) solely on account of such drug being adulterated or spurious or not of 
standard quality, as the case may be, shall be  7[punishable with imprisonment for a term which 
shall not be less than ten years but which may extend to imprisonment for life and shall also be 
liable  to  fine  which  shall  not  be  less  than  ten  lakh  rupees  or  three  times  value  of  the  drugs 
confiscated, whichever is more]: 

8[Provided  that  the  fine  imposed  on  and  released  from,  the  person  convicted  under  this 
clause  shall  be  paid,  by  way  of  compensation,  to  the  person  who  had  used  the  adulterated  or 
spurious drugs referred to in this clause: 

Provided further that where the use of the adulterated or, spurious drugs referred to in this clause 
has  caused  the  death  of  a person  who  used  such  drugs,  the  fine  imposed  on  and  realised  from,  the 
person convicted under this clause, shall be paid to the relative of the person who had died due to the 
use of the adulterated or spurious drugs referred to in this clause. 

Explanation.—For the purposes of the second proviso, the expression “relative” means—  

(i) spouse of the deceased person; or 

(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or  

(iii) parent of the minor victim; or 

1. Ins. by Act 71 of 1986, s. 2 (w.e.f. 15-9-1987). 
2. Ins. by Act 68 of 1982. s. 21 (w.e.f. 1-2-1983). 
3. Subs. by Act 26 of 2008, s. 4, for “prohibit” (w.e.f. 10-8-2009). 
4. Ins. by s. 5, ibid. (w.e.f. 10-8-2009). 
5. Subs. by Act 68 of 1982, s. 22, for sections 27 and 27A (w.e.f. 1-2-1983). 
6. Subs. by Act 26 of 2008, s. 6, for “17B or which” (w.e.f. 10-8-2009). 
7. Subs. by s. 6, ibid., for “punishable with imprisonment for a term which shall not be less than five years but which may extend 

to a term of life and with fine which shall not be less than ten thousand rupees;” (w.e.f. 10-8-2009). 

8. The provisos ins. by s. 6, ibid. (w.e.f. 10-8-2009).  

22 

 
 
                                                           
(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a son or a 

daughter who has attained the age of eighteen years; or 

(v) any person, if wholly or in part, dependent on the earnings of the deceased person at the 

time of his death,— 

(a) the parent; or 
(b) a minor brother or an unmarried sister; or 
(c) a widowed daughter-in-law; or 
(d) a widowed sister; or 
(e) a minor child of a pre-deceased son; or 
(f) a minor child of a pre-deceased daughter where no parent of the child is alive; or 
(g) the paternal grandparent if no parent of the member is alive;] 

(b) any drug—  

(i) deemed to be adulterated under section 17A but not being a drug referred to in clause (a), 

or 

(ii) without a valid licence as required under clause  (c) of section 18, 

shall  be  punishable  with  imprisonment  for  a  term  which  shall  1[not  be  less  than  three  years 
but which may extend to five years and with fine which shall not be less than one lakh rupees 
or three times the value of the drugs confiscated, whichever is more] : 

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, 
impose a sentence of imprisonment for a term of  2[less than three years and of fine of less than one 
lakh rupees]; 

 (c)  any  drug  deemed  to  be  spurious  under  section  17B,  but  not  being  a  drug  referred  to  in      

clause (a) shall be punishable with imprisonment for a term which shall  3[not less than seven years 
but which may extend to imprisonment for life and with fine which shall not be three lakh rupees or 
three times the value of the drugs confiscated, whichever is more]: 

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, 
impose a sentence of imprisonment for a term of 4[less than seven years but not less than three years 
and of fine of less than one lakh rupees]; 

(d)  any  drug,  other  than  a  drug  referred  to  in  clause  (a)  or  clause  (b)  or  clause  (c),                                         

in  contravention  of  any  other  provision  of  this  Chapter  or  any  rule  made  thereunder,  shall  be 
punishable  with  imprisonment  for  a  term  which  shall  not  be  less  than  one  year  but  which  may 
extend to two years 5[and with fine which shall not be less than twenty thousand rupees]: 

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, 

impose a sentence of imprisonment for a term of less than one year. 

27A.  Penalty 

for  manufacture,  sale,  etc.,  of  cosmetics 

in  contravention  of 

this                 

Chapter.—Whoever  himself  or  by  any  other  person  on  his  behalf  manufactures  for  sale  or  for 
distribution, or sells, or stocks or exhibits or offers for sale—  

6[(i)  any  cosmetic  deemed  to  be  spurious  under  section  17D  or  adulterated  under  section  17E 
shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  three  years  and  with  fine 
which  shall  not  be  less  than  fifty  thousand  rupees  or  three  times  the  value  of  the  cosmetics 
confiscated, whichever is more; 

1. Subs. by Act 26 of 2008, s. 6, for “not be less than one year but which may extend to three years and with fine which shall not 

be less than five thousand rupees” (w.e.f. 10-8-2009). 

2. Subs. by s. 6, ibid., for “less than one year and of fine of less than five thousand rupees” (w.e.f. 10-8-2009). 
3. Subs. by s. 6, ibid., for “not be less than three years but which may extend to five years and with fine which shall not be less 

than five thousand rupees” (w.e.f. 10-8-2009). 

4. Subs. by s. 6, ibid., for “less than three years but not less than one year” (w.e.f. 10-8-2009). 
5. Subs. by s. 6, ibid., for “and with fine” (w.e.f. 10-8-2009).  
6. Subs. by s. 7, ibid., for clauses (i) and (ii) (w.e.f. 10-8-2009).  

23 

 
                                                           
(ii) any cosmetic other than a cosmetic referred to in clause (i) in contravention of any provisions 
of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which 
may extend to one year or with fine which may extend to twenty thousand rupees, or with both. ]] 
1[28.  Penalty  for  non-disclosure  of  the  name  of  the  manufacturer,  etc.—Whoever 
contravenes  the  provisions  of  section  18A  2[or  section  24]  shall  be  punishable  with 
imprisonment for a term which may extend to one year, or 3[with fine which shall not be less 
than twenty thousand rupees or with both].] 

4[28A.  Penalty  for  not  keeping  documents,  etc.,  and  for  non-disclosure  of 
information.—Whoever  without  reasonable  cause  or  excuse,  contravenes  the  provisions  of 
section 18B shall be punishable with imprisonment for a term which may extend to one year or 
3[with fine which shall not be less than twenty thousand rupees or with both]. 

28B.  Penalty  for  manufacture,  etc.,  of  drugs  or  cosmetics  in  contravention  of      

section 26A.—Whoever himself or by any other person on his behalf manufactures or sells or 
distributes any drug or cosmetic in contravention of the provisions of any notification issued 
under  section  26A,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to 
three years and shall also be liable to fine which may extend to five thousand rupees.]  

29. Penalty for use of Government Analyst’s report for advertising.—Whoever uses any 
report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, 
or any extract from such report, for the purpose of advertising any drug  5[or cosmetic], shall be 
punishable with fine which may extend to 6[five thousand rupees]. 

7[30.  Penalty  for  subsequent  offences.—  8[(1)  Whoever  having  been  convicted  of  an            

offence,—  

(a)  under  clause  (b)  of  section  27  is  again  convicted  of  an  offence  under  that 
clause,  shall  be  punishable  with  imprisonment  for  a  term  which  shall  9[not  be  less 
than seven  years but  which may  extend to ten  years and  with  fine  which shall not be   
less than two lakh rupees]:  

Provided that the Court may, for any adequate and special reasons to be mentioned in the 
judgment, impose a sentence of imprisonment for a term of  10[less than seven  years and of 
fine of less than one lakh rupees]; 

(b)  under  clause  (c)  of  section  27,  is  again  convicted  of  an  offence  under  that  clause 
shall  be  punishable  with  imprisonment  for  a  term  which  11[shall  not  be  less  than  ten  years 
but  which  may  extend  to  imprisonment  for  life  and  with  fine  which  shall  not  be  less  than 
three lakh rupees.] 

(c) under clause (d) of section 27, is again convicted of an offence under that clause shall 
be punishable with imprisonment for a term which shall not be less than two years but which 
may extend to four years or with fine which shall not be less than  12[fifty thousand rupees], or 
with both.] 

1. Subs, by Act 13 of 1964, s. 19, for s. 28 (w.e.f. 15-9-1964). 
2. Ins. by Act 68 of 1982, s. 23 (w.e.f. 1-2-1983). 
3. Subs. by Act 26 of 2008, s. 8, for “with fine which may extend to one thousand rupees or with both” (w.e.f. 10-8-2009).  
4. Ins. by Act 68 of 1982 s. 24 (w.e.f. 1-2-1983). 
5. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964). 
6. Subs. by Act 26 of 2008, s. 10, for “five hundred rupees” (w.e.f. 10-8-2009).  
7. Subs. by Act 11 of 1955, s. 14, for s. 30. 
8. Subs. by Act 68 of 1982, s. 25, for sub-section (1) (w.e.f. 1-2-1983). 
9. Subs. by Act 26 of 2008, s. 11 for “not be less than two years but which may extend to six years and with fine which 

shall not be less than ten thousand rupees”(w.e.f. 10-8-2009). 

10. Subs. by s. 11, ibid., for “less than two years and of fine of less than ten thousand rupees (w.e.f. 10-8-2009). 
11. Subs. by s. 11, ibid., for “shall not be less than six years but which may extend to ten years and with fine which   

shall not be less than ten thousand rupees” (w.e.f. 10-8-2009).  
12. Subs. by s. 11, ibid., for “five thousand rupees” (w.e.f. 10-8-2009). 

24 

 
                                                           
1[(1A) Whoever, having been convicted of an offence under section 27A is again convicted 
under that section, shall be punishable with imprisonment for a term which may extend to two  
years, or with fine which may extend to  2[two thousand rupees], or with both.] 

(2) Whoever, having been convicted of an offence under 3*** section 29 is again convicted of an 
offence  under  the  same  section  shall  be  punishable  with  imprisonment  which  may  extend  to  4[two 
years, or with fine which shall not be less than ten thousand rupees or with both.]] 

31.  Confiscation.  —  5[(1)]  Where  any  person  has  been  convicted  under  this  Chapter  for 
contravening  any  such  provision  of  this  Chapter  or  any  rule  made  thereunder  as  may  be 
specified by rule made in this behalf, the stock of the drug  6[or cosmetic] in respect of which 
the contravention has been made shall be liable to confiscation  7[and if such contravention is in 
respect of— 

8[(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under 

section 17A or spurious under section 17B; or] 

(ii) 9[manufacture for sale, or for distribution, sale, or stocking, or exhibiting or offer ing 
for sale,] or distribution of any drug without a valid licence as required under clause  (c) of 
section 18, 

any  implements  or  machinery  used  in  such  manufacture,  sale  or  distribution  and  any  recep -
tacles packages or coverings in which such drug is contained and the animals, vehicles, vessels 
or other conveyances used in carrying such drug shall also be liable to co nfiscation]. 

10[(2)  Without  prejudice  to  the  provisions  contained  in  sub-section  (1),  where  the  Court  is 
satisfied,  on  the  application  of  an  Inspector  or  otherwise  and  after  such  inquiry  as  may  be 
necessary that the drug or cosmetic is not of standard quality 11[or is a 9[misbranded, adulterated 
or  spurious  drug  or  misbranded  or  spurious  cosmetic,]  such  drug  or,  as  the  case  may  be,  such 
cosmetic shall be liable to confiscation.] 

12[31A.  Application  of  provisions  to  Government  departments. —The  provisions  of 
this Chapter except those contained in section 31 shall apply in relation to the manufacture, 
sale  or  distribution  of  drugs  by  any  department  of  Government  as  they  apply  in  relation  to 
the manufacture, sale or distribution of drugs by any other person.]  

1. Ins. by Act 21 of 1962, s. 20 (w.e.f. 27-7-1964). 
2. Subs. by Act 68 of 1982, s. 25, for “one thousand rupees” (w.e.f. 1-2-1983). 
3. The words and figures “section 28 or” omitted by Act 13 of 1964, s. 20 (w.e.f. 15-9-1964). 
4. Subs. by Act 26 of 2008, s. 11, for “ten years or with fine or with both” (w.e.f. 10-8-2009) 
5. Re-numbered as sub-section (I) by Act 35 of 1960, s. 9 (w.e.f. 16-3-1961). 
6. Ins. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964). 
7. Added by Act 13 of 1964. s. 21 (w.e.f. 15-9-1964). 
8. Subs. by Act 68 of 1982, s. 26, for cl. (i) (w.e.f. 1-2-1983). 
9. Subs. by s. 26, ibid„ for certain words (w.e.f. 1-2-1983). 
10. Sub-section (2) ins. by Act 35 of 1960, s. 9, subs. by Act 21 of 1962, s. 21 (w. e.f. 27-7-1964). 
11. Subs. by Act 13 of 1964. s. 21, for “or is a misbranded drug” (w.e.f. 15-9-1964). 
12. Ins. by s. 22. ibid. (w.e.f. 15-9-1964). 

25 

 
 
                                                           
 
32.  Cognizance  of  offences— 1[(1) No prosecution under this Chapter shall be instituted except 

by— 

(a) an Inspector; or  

(b) any gazetted officer of the Central Government or a State Government authorised in writing in 
this behalf by the Central Government or a State Government or by a general or special order made in 
this behalf by that Government; or  

(c) the person aggrieved; or  

(d)  a  recognised  consumer  association  whether  such  person  is  a  member  of  that  association  or 

not. 

(2) Save as otherwise provided in this Act, no court inferior to that of a Court of Session shall try an 

offence punishable under this Chapter.] 

 (3)  Nothing  contained  in  this  Chapter  shall  be  deemed  to  prevent  any  person  from  being 
prosecuted  under  any  other  law  for  any  act  or  omission  which  constitutes  an  offence  against 
this Chapter. 

2[32A.  Power  of  Court  to  implead  the  manufacturer,  etc.—Where,  at  any  time  during  the 
trial of any offence under this Chapter alleged to have been committed by any person, not being 
the  manufacturer  of  a  drug  or  cosmetic  or  his  agent  for  the  distribution  thereof  the  Court  is 
satisfied, on the evidence adduced before it, that such manufacturer  or agent is also concerned in 
that  offence,  then,  the  Court  may,  notwithstanding  anything  contained  3[in  sub-sections  (1),  (2) 
and (3) of section 319 of the Code of Criminal Procedure, 1973 (2 of 1974)], proceed against him 
as though a prosecution had been instituted against him under section 32.] 

4[32B. Compounding of certain offences. — (1) Notwithstanding anything contained in the Code of 
Criminal  Procedure,  1973,  (2  of  1974)  any  offence  punishable  under  clause  (b)  of  sub-section  (1)  of 
section  13,  section  28  and  section  28A  of  this  Act  (whether  committed  by  a  company  or  any  officer 
thereof), not being an offence punishable with imprisonment only, or with imprisonment and also with fine, 
may, either before or after the institution of any prosecution, be compounded by the Central Government or by 
any  State  Government  or  any  officer  authorised  in  this  behalf  by  the  Central  Government  or  a  State 
Government, on payment for credit to that Government of such sum  as that Government may, by rules made 
in this behalf, specify: 

Provided that such sum shall not, in any case, exceed the maximum amount of the fine which may be 

imposed under this Act for the offence so compounded: 

Provided further that in cases of subsequent offences, the same shall not be compoundable. 

(2)  When  the  accused  has  been  committed  for  trial  or  when  he  has  been  convicted  and  an  appeal  is 
pending,  no  composition  for  the  offence  shall  be  allowed  without,  the  leave  of  the  court  to  which  he  is 
committed or, as the case may be, before which the appeal is to be heard. 

(3) Where an offence is compounded under sub-section (1), no proceeding or further proceeding, as 
the  case  may  be,  shall  be  taken  against  the  offender  in  respect  of  the  offence  so  compounded  and  the 
offender, if in custody, shall be released forthwith.] 

1. Subs. by Act 26 of 2008, s. 12, for sub-sections (1) and (2) (w.e.f. 10-8-2009).  
2. Ins. by Act 13 of 1964, s. 23 (w.e.f. 15-9-1964). 
3. Subs. by Act 68 of 1982, s. 28, for “in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983). 
4. Ins. by Act 26 of 2008, s. 13 (w.e.f. 10-8-2009).  

26 

 
 
 
 
 
                                                           
33.  Power  of  Central  Government  to  make  rules.  —  1[(1)  The  Central  Government  may 
2[after  consultation  with,  or  on  the  recommendation  of,  the  Board]  and  after  previous  publication 
by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions 
of this Chapter : 

Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central       

Government  is  of  opinion  that  circumstances  have  arisen  which  render  it  necessary  to  make 
rules  without  such  consultation,  but  in  such  a  case  the  Board  shall  be  consulted  within  six 
months  of  the  making  of  the  rules  and  the  Central  Government  shall  take  into  consideration 
any suggestions which the Board may make in relation to the amendment of  the said rules.] 

(2) Without prejudice to the generality of the foregoing power, such rules may —  

(a) provide  for  the  establishment  of  laboratories  for  testing  and  analysing  drugs  3[or 

cosmetics]; 

(b)  prescribe 

the  qualifications  and  duties  of  Government  Analysts  and 

the 

qualifications of Inspectors; 

(c)  prescribe the methods of test or analysis to be employed in determining whether a drug  3[or 

cosmetic] is of standard quality; 

(d)  prescribe,  in  respect  of  biological  and  organometallic  compounds,  the  units  or  methods  of 

standardisation; 

 4[(dd) prescribe under clause (d) of 5[section 17A] the colour or colours which a drug may bear 

or contain for purposes of colouring;] 

6[(dda)  prescribe  under  clause  (d)  of  section  17E  the  colour  or  colours  which  a  cosmetic  may 

bear or contain for the purposes of colouring]; 

(e) prescribe the forms of licences  7[for the manufacture for sale or for distribution], for the sale 
and  for  the  distribution  of  drugs  or  any  specified  drug  or  class  of  drugs  8[or  of  cosmetics  or  any 
specified  cosmetic  or  class  of  cosmetics],  the  form  of  application  for  such  licences,  the  conditions 
subject  to  which  such  licences  may  be  issued,  the  authority  empowered  to  issue  the  same  9[the 
qualifications  of  such  authority]  and  the  fees  payable  therefor  9[and  provide  for  the  cancellation  or 
suspension  of  such  licences  in  any  case  where  any  provision  of  this  Chapter  or  the  rules  made 
thereunder is contravened or any of the conditions subject to which they are issued is not complied 
with]; 

9[(ee)  prescribe  the  records,  registers  or  other  documents  to  be  kept  and  maintained  under     

section 18B; 

(eea)  prescribe  the  fees  for  the  inspection  (for  the  purposes  of  grant  or  renewal  of  licences)  of 

premises, wherein any drug or cosmetic is being or is proposed to be manufactured; 

(eeb)  prescribe  the  manner  in  which  copies  are  to  be  certified  under  sub-section  (2A)  of        

section 22;] 

(f)  specify  the  diseases  or ailments  which a drug may  not purport or  claim  10[to  prevent 

cure or mitigate] and such other effects which a drug may not purport or claim to have;  

1. Subs. by Act 11 of 1955, s. 15, for sub-section (1). 
2. Subs. by Act 68 of 1982, s. 29, for “after consultation with the Board” (w.e.f. 1-2-1983). 
3. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
4. Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
5. Subs. by Act 68 of 1982, s. 29, for “section 17B” (w.e.f. 1-2-1983). 
6. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009). 
7. Subs. by Act 68 of 1982, s. 29, for “for the manufacture for sale” (w.e.f. 1-2-1983). 
8. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
9. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).   
10. Subs. by Act 11 of 1955, s. 15, for “to cure or mitigate”  

27 

 
                                                           
(g)  prescribe  the  conditions  subject  to  which  small  quantities  of  drugs  may  be 

manufactured for the purpose of examination, test or analysis;  

(h)  require  the  date  of  manufacture  and  the  date  of  expiry  of  potency  to  be  clearly  and 
truly stated on the lable or container of any specified drug or class of drugs, and prohibit the 
sale stocking or exhibition for sale, or distribution of the said drug or class of drugs after the 
expiry  of  a specified  period  from  the date of  manufacture  or  after  the expiry  of the  date  of 
potency; 

(i) prescribe the conditions to be observed in the packing in bottles, packages and other containers 
of drugs 1[or cosmetics], 2[including the use of packing material which comes into direct contact with 
the  drugs]  and  prohibit  the  sale,  stocking  or  exhibition  for  sale,  or  distribution  of  drugs                     
1[or cosmetics], packed in contravention of such conditions; 

(j)  regulate  the  mode  of  labelling  packed  drugs  1[or  cosmetics],  and  prescribe  the 

matters which shall or shall not be included in such labels;  

(k)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added  to  or 
contained in any drug, prohibit the manufacture, sale or stocking or exhibition for sale, or distribution 
of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be 
poisonous for the purposes of this Chapter and the rules made thereunder; 

(l) require that the accepted scientific name of any specified drug shall be displayed in 
the  prescribed  manner  on  the  lable  or  wrapper  of  any  p atent  or  proprietary  medicine  con-
taining such drug; 

3* 

* 

* 

          *  

        * 

4[(n)  prescribe  the  powers  and  duties  of  Inspectors  2[and  the  qualifications  of  the  authority  to 
which such Inspectors shall be subordinate] and  5[specify the drugs or classes of drugs of cosmetics 
or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to 
which,  such powers and duties may be exercised or performed;] 

(o)  prescribe  the  forms  of  report  to  be  given  by  Government  Analysts,  and  the  manner  of 

application for test or analysis under section 26 and the fees payable therefor; 

6[(p) specify the offences against this Chapter or any rule made thereunder in relation to which an 

order of confiscation may be made under section 31; 7***]  

(q) provide for the exemption conditionally or otherwise, from all or any of the provisions of this 
Chapter or the rules made thereunder, of any specified drug or class of drugs 1[or cosmetic or class of 
cosmetics] 8[and]; 

1. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
2. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983). 
3. Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
4. Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961). 
5. Subs. by Act 21 of 1962, s. 22, for “the drugs or class of drugs” (w.e.f. 27-7-1964). 
6. Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964). 
7. The word “and” omitted by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009). 
8. Ins. by, s. 14 ibid. (w.e.f. 10-8-2009). 

28 

 
                 
 
 
 
 
                                                           
1[(r) sum which may be specified by the Central Government under section 32B.] 

2* 

* 

     * 

             * 

* 

3[33A.  Chapter  not  to  apply  to  Ayurvedic,  Siddha  or  Unani  drugs.—  Save  as  otherwise 
provided in this Act, nothing contained in this Chapter shall apply to  4[Ayurvedic, Siddha 
or Unani] drugs.] 

5[CHAPTER IVA 

PROVISIONS RELATING TO  4[AYURVEDIC, SIDDHA AND UNANI] DRUGS 

 33B.  Application  of  Chapter  IVA.—This  Chapter  shall  apply  only  to  4[Ayurvedic,  Siddha  and 

Unani] drugs. 

33C.  Ayurvedic  and  Unani  Drugs  Technical  Advisory  Board.  —(1)  The  Central  Government 
shall, by notification in the Official Gazette and with effect from such date as may be specified therein, 
constitute a Board (to be called the 6[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to 
advise  the  Central  Government  and  the  State  Governments  on  Technical  matters  arising  out  of  this 
Chapter and to carry out the other functions assigned to it by this Chapter. 

(2) The Board shall consist of the following members, namely: — 

(i) the Director General of Health Services ex officio; 

(ii) the Drugs Controller, India, ex officio; 

7[(iii)  the  principal  officer  dealing  with  Indian  systems  of  medicine  in  the  Ministry  of  Health,      

ex officio];  

 (iv) the Director of the Central Drugs Laboratory, Calcutta ex officio; 

(v)  one  person  holding  the  appointment  of  Government  Analyst  under  section  33F,  to  be 

nominated by the Central Government; 

(vi) one Pharmacognocist to be nominated by the Central Government;  

(vii) one Phyto-chemist to be nominated by the Central Government;  

1. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009). 
2. Sub-section (3) ins. by Act 35 of 1960, omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
3. Ins. by Act 13 of 1964, s. 25 (w.e.f. 1-2-1969). 
4. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
5. Ins. by Act 13 of 1964, s. 26 (w.e.f. 1-2-1969). 
6. Subs. by Act 68 of 1982, s. 30, for certain words (w.e.f. 1-2-1983). 
7. Subs. by s. 30, ibid., for cl. (iii) (w.e.f. 1-2-1983). 

29 

 
 
 
 
 
 
 
 
 
                                                           
1[(viii) four persons to be nominated by the Central Government, two from amongst the members 
of  the  Ayurvedic  Pharmacopoeia  Committee,  one  from  amongst  the  members  of  the  Unani 
Pharmacopoeia  Committee  and  one  from  amongst  the  members  of  the  Siddha  Pharmacopoeia 
Committee;] 

(ix)  one  teacher  in  Darvyaguna,  and  Bhaishajya  Kalpana,  to  be  nominated  by  the  Central 

Government; 

(x)  one  teacher  in  ILM-UL-ADVIA  and  TAKLIS-WA-DAWASAZI,  to  be  nominated  by  the 

Central Government; 

2[(xi) one teacher in Gunapadam to be nominated by the Central Government;  

(xii)  three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be 

nominated by the Central Government; 

(xiii)  three  persons,  one  each  from  among  the  practitioners  of  Ayurvedic,  Siddha 

and Unani Tibb systems of medicine to be nominated by the Central Government.]  

(3) The Central Government shall appoint a member  of the Board as its Chairman.  

(4)  The nominated members of the Board shall hold office for three years but shall be eligible for 

renomination. 

(5) The  Board  may,  subject  to  the  previous  approval  of  the  Central  Government,  make  bye -
laws  fixing  a  quorum  and  regulating  its  own  procedure  and  conduct  of  all  business  to  be  tran -
sacted by it. 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.  

(7)  The  Central  Government  shall  appoint  a  person  to  be  Secretary  of  the  Board  and 
shall  provide  the  Board  with  such  clerical  and  other  staff  as  the  Central  Government 
considers necessary. 

3[33D.  The  Ayurvedic,  Siddha  and  Unani  Drugs  Consultative  Committee. —(1)  The 
Central  Government  may  constitute  an  Advisory  Committee  to  be  called  the  Ayurvedic, 
Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State 
Governments  and  the  Ayurvedic,  Siddha  and  Unani  Drugs  Technical  Advisory  Board  on  any 
matter  for  the  purpose  of  securing  uniformity  throughout  India  in  the   administration  of  this 
Act in so far as it relates to Ayurvedic, Siddha or Unani drugs. 

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two 
persons  to  be  nominated  by  the  Central  Government  as  representatives  of  that  Gove rnment 
and not more than one representative of each State to be nominated by the State Government 
concerned. 

(3)  The  Ayurvedic,  Siddha  and  Unani   Drugs  Consultative  Committee  shall  meet  when 

required to do so by the Central Government and shall regulate its own procedure.  

1. Subs. by Act 68 of 1982, s. 30, for cl. (viii) (w.e.f. 1-2-1983). 
2. Subs. by s. 30, ibid., for cls. (xi) and (xii) (w.e.f. 1-2-1983). 
3. Subs. by s. 31, ibid., for sections.33D and 33E (w.e.f. 1-2-1983). 

30 

 
 
 
                                                           
33E.  Misbranded  drugs.—For  the  purposes  of  this  Chapter,  an  Ayurvedic,  Siddha  or  Unani  drug 

shall be deemed to be misbranded— 

(a)  if  it  is  so  coloured,  coated,  powdered  or  polished  that  damage  is  concealed,  or  if 

it is made to appear of better or greater therapeutic value than it really is; or  

(b) if it is not labelled in the prescribed manner; or  

(c)  if  its  label  or  container  or  anything  accompanying  the  drug  bears  any  statement, 
design or device which makes any false claim for the drug or which is false or misleading in 
any particular. 

33EE. Adulterated drugs.—For the purposes of this Chapter, an Ayurve dic, Siddha or 

Unani drug shall be deemed to be adulterated, —  

(a) if  it  consists,  in  whole  or  in  part,  of  any  filthy,  putrid  or  decomposed  substance; 

or 

(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it 
may have been contaminated with filth or whereby it may have been rendered injurious to 
health; or 

(c)  if  its  container  is  composed,  in  whole  or  in  part,  of  any  poisonous  or  deleterious 

substance which may render the contents injurious to health; or  

(d)  if  it  bears  or  contains,  for  purposes  of  colouring  only,  a  colour  other  than  one  which  is 

prescribed; or 

(e)  if  it  contains  any  harmful  or  toxic  substance  which  may  render  it  injurious  to 

health; or 

(f) if any substance has been mixed therewith so as to reduce its quality or strength.  

Explanation.—For the purpose of clause (a), a drug shall not be deemed to consist, in whole 
or  in  part,  of  any  decomposed  substance  only  by  reason  of  the  fact  that  such  decomposed 
substance is the result of any natural decomposition of the drug:  

Provided that such decomposition is not due to any negligence on the part of the manufac -

turer of the drug or the dealer thereof and that it does not render the drug injurious to  health. 

33EEA.  Spurious  drugs.—For  the  purposes  of  this  Chapter,  an  Ayurvedic,  Siddha  or  Unani  drug 

shall be deemed to be spurious— 

(a) if  it  is  sold,  or  offered  or  exhibited  for  sale,  under  a  name  which  belongs  to  another 

drug; or  

(b) if it is an imitation of, or is substitute for, another drug or resembles another drug in 
a  manner  likely  to  deceive,  or  bears  upon  it  or  upon  its  label  or  container  the  name  of 
another drug, unless it is plainly and conspicuously marked so as to reveal its true chara cter 
and its lack of identity with such other drug; or 

(c)  if  the  label  or  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the drug, which individual or company is fictitious or does not exist; or 

(d) if it has been substituted wholly or in part by any other drug or substance; or  

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.  

33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs. —No 
person shall manufacture for sale or for distribution any Ayurvedic, Siddha and Unani drug except 
in accordance with such standards, if any, as may be prescribed in relation to that drug.  

31 

 
33EEC.  Prohibition  of  manufacture  and  sale  of  certain  Ayurvedic ,  Siddha  and  Unani 
drugs.—From  such  date  as  the  State  Government  may,  by  notification  in  the  Official  Gazette, 
specify in this behalf, no person, either by himself or by any other person on his behalf, shall —  

(a) manufacture for sale or for distribution— 

(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug;  

(ii)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed 
manner on the label or container thereof the true list of all the ingredients contained in it; 
and 

(iii)  any  Ayurvedic,  Siddha  or  Unani  drug  in  contravention  of  any  of  the 

provisions of this Chapter or any rule made thereunder;  

(b)  sell,  stock  or  exhibit  or  offer  for  sale  or  distribute  any  Ayurvedic,  Siddha  or  Unani  drug 
which has been manufactured in contravention of any of the provisions of this Act, or any rule made 
thereunder, 

(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug except under, 
and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the 
prescribed authority : 

Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, 

Siddha or Unani drug for the use of their own patients : 

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed 
conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, 
test or analysis. 

33EED.  Power  of  Central  Government  to  prohibit  manufacture,  etc.,  of  Ayurvedic, 
Siddha or Unani drugs in public interest.—Without prejudice to any other provision contained in 
this Chapter, if the Central Government is satisfied on the basis of any evidence or other material 
available before it that the use of any Ayurvedic, Siddha or Unani drug is likely to involve any risk 
to  human  being  or  animals  or  that  any  such  drug  does  not  have  the  therapeutic  value  claimed  or 
purported to be claimed for it and that in the public interest it is necessary or expendient so to do 
then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale 
or distribution of such drug.] 

33F.  Government  Analysts.—(1)  The  Central  Government  or  a  State  Government  may,  by 
notification  in  the  Official  Gazette,  appoint  such  persons  as  it  thinks  fit,  having  the  prescribed 
qualifications,  to  be  Government  Analysts  for  such  areas  as  may  be  assigned  to  them  by  the  Central 
Government or the State Government, as the case may be. 

(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor 
a  State  Government  shall  appoint  as  a  Government  Analysts  any  official  not  serving  under  it 
without the previous consent of the Government under which he is serving. 

1[(3)  No  person  who  has  any  financial  interest  in  the  manufacture  or  sale  of  any  drug  shall  be 

appointed to be a Government Analysts under this section.] 

33G. Inspectors.—(1) The Central Government or a State Government may, by notification in the 
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications to be Inspectors 
for such areas as may be assigned to them by the Central Government or the State Government, as the 
case may be. 

(2)  The  powers  which  may  be  exercised  by  an  Inspector  and  the  duties  which  may  be 
performed  by  him  and  the  conditions,  limitations  or  restrictions  subject  to  which  such  powers 
and duties may be exercised or performed shall be such as may be prescribed.  

1. Ins. by Act 68 of 1982, s. 32 (w.e.f. 1-2-1983). 

32 

 
                                                           
(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed 

to be an Inspector under this section. 

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 
of  the  Indian  Penal  Code  (45  of  1860)  and  shall  be  officially  subordinate  to  such  authority  as 
the Government appointing him may specify in this behalf. 

33H.  Application  of  provisions  of  sections  22,  23,  24  and  25.—The  provisions  of       

sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in 
relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in 
relation  to  an  Inspector  and  a  Government  Analyst  appointed  under  Chapter  IV,  subject  to  the 
modification that the references to “drug” in the said sections, shall be construed as references to 
1[Ayurvedic, Siddha or Unani] drug. 

2[33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention 

of this Chapter.—Whoever himself or by any other person on his behalf—  

(1) manufactures for sale or for distribution, — 

3[(a) any Ayurvedic, Siddha or Unani drug—  

(i) deemed to be misbranded under section 33E, 
(ii) deemed to be adulterated under section 33EE, or 
(iii)  without a valid licence or in violation of any of the conditions thereof, as required 

under section 33 EEC, 

shall be punishable with imprisonment for a term which may extend to one year and with fine which 
shall  not  be  less  than  twenty  thousand  rupees  or  three  times  the  value  of  the  drugs  confiscated, 
whichever is more;] 

(b)  any  Ayurvedic,  Siddha  or  Unani  drug  deemed 

to  be  spurious  under            

section  33EEA,  shall  be  punishable  with  imprisonment  for  a  term  which  shall  not  be 
less than one year but which may extend to three years and with fine which shall not be 
less than  4[fifty thousand rupees or three times the value of the drugs confiscated, whichever is 
more]: 

Provided that the Court may, for any adequate and special reasons to be mentioned 
in  the  judgment,  impose  a  sentence  of  imprisonment  for  a  term  of  less  than  one  year 
and  of  fine  of  less  than  4[fifty  thousand  rupees  or  three  times  the  value  of  the  drugs 
confiscated, whichever is more]; or 

5[(c)  any  Ayurvedic,  Siddha  or  Unani  drug  in  contravention  of  the  provisions  of  any 
notification issued under section 33EED shall be punishable with imprisonment for a term which 
may extend to three years and with fine which may extend to fifty thousand rupees or three times 
the value of the drugs confiscated, whichever is more.] 

 (2)  Contravenes  any  other  provisions  of  this  Chapter  or  of  section  24  as  applied  by              

section 33H or any rule made under this Chapter, shall be punishable with imprisonment for a 
term  which  may  extend  to  6[six  months  and  with  fine  which  shall  not  be  less  than  ten  thousand 
rupees]. 

33J. Penalty for subsequent offences.—Whoever having been convicted of an offence,— 
(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence 
under  that  clause,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to 
two years and with fine which shall not be less than   7[fifty  thousand rupees or three times the 
value of the drugs confiscated, whichever is more]; 

(b)  under  clause  (b)  of  sub-section  (1)  of  section  33-I  is  again  convicted  of  an  offence 
under that clause, shall be punishable with imprisonment for a term which shall not be less 
than two years but which may be extend to six years and with fine which shall not be less   

1. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
2. Subs. by s. 33, ibid., for sections 33-I and 33J (w.e.f. 1-2-1983). 
3. Subs. by Act 26 of 2008, s. 15, for clause (a) (w.e.f. 10-8-2009).  
4. Subs. by s. 15, ibid., for “five thousand rupees” (w.e.f. 10-8-2009). 
5. Ins. by s. 15, ibid. (w.e.f. 10-8-2009). 
6. Subs. by s. 15, ibid., for “three months and with fine which shall not be less than five hundred rupees” (w.e.f. 10-8-2009). 
7. Subs, by s. 16, ibid., for “two thousand rupees” (w.e.f. 10-8-2009). 

33 

 
                                                           
than1[one lakh rupees or three times the value of the drugs confiscated, whichever is more]: 

Provided that the Court may, for any adequate and special reasons to be mentioned in 
the judgment, impose a sentence of imprisonment for a term of less than two years and of 
fine  of  less  than  1[one lakh rupees or three times the value of the drugs confiscated, whichever is 
more;] 

(c) under  sub-section  (2)  of section  33-I  is  again  convicted  of  an  offence  under  that 
sub-section, shall be punishable with imprisonment for a term which may  extend to 2[one 
year and with fine which shall not be less than twenty thousand rupees or three times the value of the 
drugs confiscated, whichever, is more]. 

33K. Confiscation.—Where any person has been convicted under this Chapter, the stock of 
the  3[Ayurvedic,  Siddha  or  Unani]  drug,  in  respect  of  which  the  contravention  has  been  made, 
shall be liable to confiscation. 

4[33KA. Disclosure of name of manufacturer, etc. — Every person, not being the manufacturer 
of  any  Ayurvedic,  Siddha  or  Unani  drug  or  his  agent  for  the  distribution  thereof,  shall,  if  so  required, 
disclose to the Inspector the name, address and .other particulars of the person from whom he acquired the 
Ayurvedic, Siddha or Unani drug. 

33KB. Maintenance of records and furnishing of information.  — Every person holding a licence 
under clause (c) of section 33EEC shall keep and maintain such records, registers and other documents as 
may be prescribed and shall furnish to any officer or authority exercising any power or discharging any 
function under this Act such information as is required by such officer or authority for carrying out the 
purposes of this Act.] 

33L.  Application  of  provisions  to  Government  departments.—The  provisions  of  this 
Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, 
sale,  or  distribution  of  any  3[Ayurvedic,  Siddha  or  Unani]  drug  by  any  department  of 
Government  as  they  apply  in  relation  to  the  manufacture  for  sale,  sale,  or  distribution  of  such 
drug by any other person. 

33M.  Cognizance  of  offences.—(1)  No  prosecution  under  this  Chapter  shall  be  instituted 

except  by  an  Inspector  5[with  the  previous  sanction  of  the  authority  specified  under                
sub-section (4) of section 33G]. 

(2)  No  Court  inferior  to  that  6[of  a  Metropolitan  Magistrate  or  of  a  Judicial  Magistrate 

of the first class] shall try an offence punishable under this Chapter.  

33N.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may, 
7[after  consultation  with,  or  on  the  recommendation  of,  the  Board]  and  after  previous  publication 
by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions 
of this Chapter: 

Provided that consultation with the Board may be dispensed with if the Central Government is of 
opinion that circumstances have arisen which render it necessary to make rules without such consultation, 
but in such a case, the Board shall be consulted within six months of the making of the rules and the 
Central Government shall take into consideration any suggestions which the Board may make in relation 
to the amendment of the said rules. 

(2) Without prejudice to the generality of the foregoing power, such rules may —  

(a) provide for the establishment of laboratories for testing and analysing  3[Ayurvedic, Siddha or 

Unani] drugs; 

1. Subs. by Act 26 of 2008 s. 16, for “five thousand rupees” (w.e.f. 10-8-2009). 
2.  Subs.  by  s.  16,  ibid.,  for  “six  months  and  with  fine  which  shall  not  be  less  than  one  thousand  rupees ”                         
(w.e.f. 10 -8-2009). 
3. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
4. Ins. by Act 26 of 2008, s. 17 (w.e.f. 10-8-2009). 
5. Ins. by Act 68 of 1982, s. 34 (w.e.f. 1-2-1983). 
6. Subs. by s. 34, ibid., for “of a Presidency Magistrate or of a Magistrate of the first class” (w.e.f. 1-2-1983). 
7. Subs. by s. 35, ibid., “after consultation with the Board” (w.e.f. 1-2-1983).  

34 

 
                                                           
(b)  prescribe 

the  qualifications  and  duties  of  Government  Analysts  and 

the 

qualifications of Inspectors; 

(c)  prescribe  the  methods  of  test  or  analysis  to  be  employed  in  determining  whether  any 
1[Ayurvedic,  Siddha  or  Unani]  drug  is  labelled  with  the  true  list  of  the  ingredients  which  it  is 
purported to contain: 

(d) specify any substance as a poisonous substance;  
(e) prescribe the forms of licences for the manufacture for sale of  1[Ayurvedic, Siddha or 
Unani]  drugs  2[and  for  sale  of  processed  Ayurvedic,  Siddha  or  Unani  drugs,]  the  form  of 
application  for  such  licences,  the  conditions  subject  to  which  such  licences  may  be  issued, 
the  authority  empowered  to  issue  the  same  and  the  fees  payable  therefor;  2[and  provide  for 
the  cancellation  or  suspension  of  such  licences  in  any  case  where  any  provision  of  this 
Chapter  or  rules  made  thereunder  is  contravened  or  any  of  the  cond itions  subject  to  which 
they are issued is not complied with]; 

3[(f)  prescribe  the  conditions  to  be  observed  in  the  packing  of  Ayurvedic,  Siddha  and 
Unani drugs including the use of packing material which comes into direct contact with the 
drugs, regulate the mode of labelling packed drugs and prescribe the matters which shall or 
shall not be included in such labels;] 

(g) prescribe the conditions subject to which small quantities of  1[Ayurvedic, Siddha 
or  Unani]  drugs  may  be  manufactured  for  the  purpose  of  examination,  test  or  analysis; 
and  

4[(gg)  prescribe  under  clause  (d)  of  section  33EE  the  colour  or  colours  which  an 

Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;  

(gga)  prescribe  the  standards  for  Ayurvedic,  Siddha  or  Unani  drugs  under     

section 33EB;] 

5[(ggb)  prescribe  the  records,  registers  or  the  documents  to  be  kept  and 

maintained under section 33KB; and]   

 (h) any other matter which is to be or may be prescribed under this Chapter.  

33-O.  Power  to  amend  First  Schedule.—The  Central  Government,  after  consultation  with 
the Board and after giving, by notification in the Official Gazette, not less than three months ’ 
notice of its intention so to do, may, by a like notification, add to or otherwise amend the First 
Schedule  for the  purposes  of  this  Chapter  and  thereupon  the  said  Schedule  shall  be  deemed  to 
be amended accordingly. 

6[CHAPTER V  
MISCELLANEOUS 

7[  8[33P.]  Power  to  give  directions.—The  Central  Government  may  give  such  directions 
to  any  State  Government  as  may  appear  to  the  Central  Government  to  be   necessary  for 
carrying  into  execution  in  the  State  any  of  the  provisions  of  this  Act  or  of  any  rule  or  order 
made thereunder.]  

34. Offences by companies.—(1) Where an offence under this Act has been committed by a 
company,  every  person  who  at  the  time  the  offence  was  committed,  was  in  charge  of  and  was 
responsible  to  the  company  for  the  conduct  of  the  business  of  the  company,  as  well  as  the 

1. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
2. Ins. by s. 35, ibid. (w.e.f. 1-2-1983). 
3. Subs. by s. 35, ibid., for cl. (f) (w.e.f. 1-2-1983). 
4. Ins. by s. 35, ibid. (w.e.f 1-2-1983). 
5.  Ins. by Act 26 of 2008 s. 18 (w.e.f. 10-8-2009). 
6. Subs. by Act 11 of 1955, s. 16, for s. 34. 
7. Ins. by Act 35 of 1960, s. 11 (w.e.f. 16-3-1961). 
8. S. 33A re-numbered as s. 33P by Act 13 of 1964, s. 27 (w.e.f. 15-9-1964). 

35 

 
                                                           
company shall be deemed to be guilty of the offence and shall be liable to be proceeded against 
and punished accordingly: 

Provided  that  nothing  contained  in  this  sub -section  shall  render  any  such  person  liable 
to  any  punishment  provided  in  this  Act  if  he  proves  that  the  offen ce  was  committed 
without  his  knowledge  or  that  he  exercised  all  due  diligence  to  prevent  the  commission  of 
such offence. 

(2) Notwithstanding anything contained in sub -section (1), where an offence under this Act 
has  been  committed  by a  company  and  it  is  proved  that  the offence  has  been  committed  with 
the  consent  or  connivance  of,  or  is  attributable  to  any  neglect  on  the  part  of,  any  director, 
manager, secretary or other officer of the company, such director, manager, secretary or o ther 
officer  shall  also  be  deemed  to  be  guilty  of  that  offence  and  shall  be  liable  to  be  proceeded 
against and punished accordingly. 

Explanation.—For the purposes of this section—  

(a) “company” means a body corporate, and includes a firm or other association of individuals; 

and 

(b) “director” in relation to a firm means a partner in the firm.  

1[34A.  Offences  by  Government  departments.—Where  an  offence  under  Chapter  IV  or 
Chapter  IVA  has  been  committed  by  any  department  of  Government,  such  authority  as  is 
specified  by  the  Central  Government  to  be  in  charge  of  manufacture,  sale,  or  distribution  of 
drugs  or  where  no  authority  is  specified,  the  head  of  the  department  shall  be  deemed  to  be 
guilty of the offence and shall be liable to be proceeded against and punished accordingly:  

Provided  that  nothing  contained  in  this  section  shall  render  any  such  authority  or  person 
liable to any punishment provided in Chapter IV or Chapter IVA, as the case may be , if such 
authority or person proves that the offence was committed without its or his knowledge or that 
such  authority  or  person  exercised  all  due  diligence  to  prevent  the  commission  of  such 
offence.] 

2[34AA. Penalty for vexatious search or seizure.—Any Inspector exercising powers under this Act 

or the rules made thereunder, who,—  

(a)  without  reasonable  ground  of  suspicion  searches  any  place,  vehicle,  vessel  or  other 

conveyance; or 

(b) vexatiously and unnecessarily searches any person; or  

(c)  vexatiously  and  unnecessarily  seizes  any  drug  or  cosmetic,  or  any  substance  or 

article, or any record, register, document or other material object; or  

(d)  commits,  as  such  Inspector,  any  other  act,  to  the  injury  of  any  person  without 

having reason to believe that suc h act is require for the execution of his duty,  

shall be punishable with fine which may extend to one thousand rupees.]  

35. Publication of sentences passed under this Act.—(1) If any person is convicted of an 
offence  under  this  Act,  3[the  Court  before  which  the  conviction  takes  place  shall,  on 
application  made  to  it  by  the  Inspector   cause]  the  offender’s  name,  place  of  residence,  the 
offence of which he has been convicted and the penalty which has been inflicted upon him, to 
be published at the expense  of such person in such newspapers or in such other manner as the 
Court may direct. 

(2) The expenses of such publication shall be deemed to form part of the costs relating 
to  the  conviction  and  shall  be  r ecoverable  in  the  same  manner  as  those  costs  are 
recoverable. 

1. Ins. by Act 13 of 1964, s. 28 (w.e.f. 15-9-1964). 
2. Ins. by Act 68 of 1982, s. 36 (w.e.f. 1-2-1983).  
3. Subs. by s. 37, ibid., for certain words (w.e.f. 1-2-1983). 

36 

 
                                                           
36.  Magistrate’s  power  to  impose  enhanced  penalties.—Notwithstanding  anything 
contained in  1* * *  2[the Code of Criminal Procedure, 1973 (2 of 1974)], it shall  be lawful for 
3[any  Metropolitan  Magistrate  or  any  Judicial  Magistrate  of  the  first  class]  to  pass  any 
sentence authorized by this Act in excess of his powers under  1* * * the said Code. 

4[36A.  Certain  offences  to  be  tried  summarily.—Notwithstanding  anything  contained  in 
the Code of Criminal Procedure, 1973 (2 of 1974),  5[all offences (except the offences triable by 
the  Special  Court  under  section  36AB  or  Court  of  Session   under  this  Act]  punishable  with 
imprisonment  for  a  term  not  exceeding  three  years,  other  than  an  offence  under  clause  (b)  of 
sub-section (1) of section 33-I, shall be tried in a summary way by a  Judicial Magistrate of the 
first  class  specially  empowered  in  this  behalf  by  the  State  Government  or  by  a  Metropolitan 
Magistrate and the provisions of sections 262 to 265 (both inclusive) of the said Code shall, as 
far as may be, apply to such trial : 

Provided that, in the case of any conviction in a summary trial under this secti on, it shall 
be  lawful  for  the  Magistrate  to  pass  a  sentence  of  imprisonment  for  a  term  not  exceeding 
one year: 

Provided  further  that  when  at  the  commencement  of,  or  in  the  course  of,  a  summary  trial 
under this section it appears to the Magistrate that the  nature of the case is such that a sentence 
of imprisonment for a term exceeding one year may have to be passed or that it is, for any other 
reason,  undesirable  to  try  the  case  summarily,  the  Magistrate  shall,  after  hearing  the  parties,  
record  an  order  to  that  effect  and  thereafter  recall  any  witness  who  has  been  examined  and 
proceed to hear or rehear the case in the manner provided by the said Code.]  

6[36AB. Special Courts. — (1)  The Central Government, or the State Government, in consultation with 
the Chief Justice of the High Court, shall, for trial of offences relating to adulterated drugs or spurious drugs 
and punishable under clauses (a) and (b) of section 13, sub-section (3) of section 22, clauses (a) and (c) of 
section 27,  section  28, section  28A, section  28B  and clause  (b) of  sub-section (1) of section  30  and other 
offences  relating  to  adulterated  drugs  or  spurious  drugs,  by  notification,  designate  one  or  more  Courts  of 
Session as a Special Court or Special Courts for such area or areas or for such case or class or group of cases 
as may be specified in the notification. 

Explanation.  —In  this  sub-section,  “High  Court”  means  the  High  Court  of  the  State  in  which  a 

Court of Session designated as Special Court was functioning immediately before such designation. 

(2) While trying an offence under this Act, a Special Court shall also try an offence, other than an 
offence  referred  to  in  sub-section  (1),  with  which  the  accused  may,  under  the  Code  of  Criminal 
Procedure, 1973 (2 of 1974), be charged at the same trial. 

36AC.  Offences  to  be  cognizable  and  non-bailable  in  certain  cases.  —  (1)  Notwithstanding 

anything contained in the Code of Criminal Procedure, 1973 (2 of 1974),— 

(a) every offence, relating to adulterated or spurious drug and punishable under clauses (a) and 
(c) of sub-section (1) of section 13, clause (a) of sub-section (2) of section 13, sub-section (3) of 
section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and sub-sections 
(1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, shall be 
cognizable. 

1. The words and figures “section 32 of” omitted by Act 13 of 1964, s. 29 (w.e.f. 15-9-1964).  
2. Subs. by Act 68 of 1982, s. 38, for “the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983). 
3. Subs. by s. 38, ibid., for “any Presidency Magistrate or any Magistrate of the first class” (w.e.f. 1-2-1983). 
4. Ins. by s. 39, ibid. (w.e.f. 1-2-1983). 
5. Subs. by Act 26 of 2008, s. 19, for “all offences under this Act” (w.e.f. 10-8-2009).  
6. Ins. by s. 20, ibid. (w.e.f. 10-8-2009). 

37 

 
 
                                                           
(b) no person accused, of an offence punishable under clauses  (a). and (c) of sub-section (1) of 
section 13, clause (a) of sub-section (2) of section 13, sub-section (3) of section 22, clauses (a) and 
(c) of section 27, section 28, section 28A, section 28B and sub-sections (1) and (2) of section 30 and 
other offences relating to adulterated drugs or spurious drugs, shall be released on bail or on his own 
bond unless—  

(i)  the  Public  Prosecutor  has  been  given  an  opportunity  to  oppose  the  application  for  such 

release; and 

(ii) where the Public Prosecutor opposes the application, the court is satisfied that there are 
reasonable grounds for believing that he is not guilty of such offence and that he is not likely to 
commit any offence while on bail: 

Provided that a person, who, is under the age of sixteen years, or is a woman or is sick or infirm, may 

be released on bail, if the Special Court so directs. 

(2) The limitation on granting of bail specified in clause  (b) of sub-section (1) is in addition to the 
limitations under the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in 
force on granting of bail. 

(3)  Nothing  contained  in  this  section  shall  be  deemed  to  affect  the  special  powers  of  the  High  Court 
regarding bail under section 439 of the Code of Criminal Procedure, 1973 (2 of 1974) and the High Court 
may exercise such powers including the power under clause (b) of sub-section (1) of that section as if the 
reference to “Magistrate” in that section includes also a reference to a  “Special Court” designated under 
section 36AB. 

36AD.  Application  of  Code  of  Criminal  Procedure,  1973  to  proceedings  before  Special             

Court.  —  (1) Save as  otherwise  provided in this  Act, the provisions  of the  Code of  Criminal  Procedure, 
1973 (2 of 1974) (including the provisions as to bails or bonds), shall apply to the proceedings before a 
Special Court and for the purposes of the said provisions, the  
Special  Court  shall  be  deemed  to  be  a 
Court of Session and the person conducting the prosecution before the Special Court, shall be deemed to be 
a Public Prosecutor:  

Provided that the Central Government or the State Government may also appoint, for any case or class 

or group of cases, a Special Public Prosecutor. 

(2)  A person shall not be qualified to be appointed as a Public Prosecutor or a Special Public Prosecutor 
under this section unless he has been in practice as an advocate for not less, than seven years, under the Union or 
a State, requiring special knowledge of law. 

(3) Every person appointed as a Public Prosecutor or a Special Public Prosecutor under this section shall 
be deemed to be a Public Prosecutor within the meaning of clause (u) of section 2 of the Code of Criminal 
Procedure, 1973 (2 of 1974)  and the provisions of that Code shall have effect accordingly. 

36AE. Appeal and revision. — The High Court may exercise, so far as may be applicable, all the 
powers conferred by Chapter XXIX or Chapter XXX of the Code of Criminal Procedure, 1973 (2 of 1974), on a 
High Court, as if a Special Court within the local limits of the jurisdiction of the High Court were a Court of 
Session trying cases within the local limits of the jurisdiction of the High Court.] 

37. Protection of action taken in good faith.—No suit, prosecution or other legal proceeding shall 

lie against any person for anything which is in good faith done or intend to be done under this Act]. 

1[38.  Rules  to  be  laid  before  Parliament.—Every  rule  made  under  this  Act  shall  be  laid  as 
soon as  may be  after it is  made before each House  of  Parliament  while it is  in session for a total 
period of thirty days which may be comprised in one session or in two or more successive sessions, 
2[and  if,  before  the  expiry  of  the  session  immediately  following  the  session  or  the  successive 
sessions aforesaid], both Houses agree in making any modification in the rule or both Houses agree 
that the rule should not be made, the rule shall thereafter have effect only in such modified form or 
be of no effect, as the case may be; so, however, that any such modification or annulment shall be 
without prejudice to the validity of anything previously done under that rule.]  

1. Ins. by Act 13 of 1964, s. 30 (w.e.f. 15-9-1964). 
2. Subs. by Act 68 of 1982, s. 40, for certain words (w.e.f. 1-2-1983). 

38 

 
 
                                                           
1[THE FIRST SCHEDULE  

[See section 3 (a)] 
2[A.—AYURVEDIC AND SIDDHA SYSTEMS] 

SI. No.  Name of book 

1.  Arogya Kalpadruma 

      2.  Arka Prakasha  
      3.  Arya Bhishak  

4.  Ashtanga Haridaya  
5.  Ashtanga Samgraha  
6.  Ayurveda Kalpadruma 
7.  Ayurveda Prakasha 
8.  Ayurveda Samgraha 
9.  Bhaishajya Ratnavali 
10.  Bhart Bhaishajya Ratnakara 
11.  Bhava Prakasha 
12.  Brihat Nighantu Ratnakara 
13.  Charaka Samhita 
14.  Chakra Datta 
15.  Gada Nigraha 
16.  Kupi Pakva Rasayana 
17.  Nighanttu Ratnakara 
18.  Rasa Chandanshu 
19.  Rasa Raja Sundara 
20.  Rasaratna Samuchaya 
21.  Rasatantra Sara Siddha 
  Prayoga Samgraha 

3[21A. Rastantra Sar Va Siddha Prayog  
  Samgraha Part II (Edition 2006).] 

20212132002002006)] 

22.  Rasa Tarangini 
23.  Rasa Yoga Sagara 
24.  Rasa Yoga Ratnakara 
25.  Rasa Yoga Samgraha 
26.  Rasendra Sara Samgraha 
27.  Rasa Pradipika 

SI. No.  Name of book 
Ayurveda  
29. 
  30. 
31. 
32. 
33. 
34. 
35. 
36. 
37. 
38. 
39. 
40. 
41. 
42. 
43. 
44. 
45. 
46. 
47. 
48. 
49. 
50. 
51. 
52. 
53. 
54. 
4[54A. 
54B 
6[54C 
3[54D  Ayurvedic Pharmacopoeia  

Sarvaroga Chikitsa Ratnam 
Sarvayroga Chikitsa Ratnam 
Sharangadhara Samhita 
Siddha Bhaishajya Manimala 
Siddha Yoga Samgraha 
Sushruta Samhita 
Vaidya Chintamani 
Vaidyaka Shabda Sindu 
Vaidyaka Chikitsa Sara 
Vaidya Jiwan 
Basava Rajeeyam 
Yoga Ratnakara 
Yoga Tarangini 
Yoga Chintamani 
Kashyapasamhita 
Bhelasamhita 
Vishwanathachikitsa 
Vrindachikitsa 
Ayurvedachintamani 
Abhinavachintamani 
Ayurveda-ratnakar 
Yoga ratnasangraha 
Rasamrita 
Dravyagunanighantu 
Rasamanjari 
Bangasena 
5[Ayurvedic Formulary of India and its Parts] 
Aurveda Sara Sangraha] 
Aurvedic Pharmacopoeia of india.] 

    28.    Sahasrayoga 

 of India and its Parts] 

Siddha  

61. 
55.  Siddha Vaidya Thirattu 
56.  Therayar Maha Karisal 
62. 
57.  Brahma Muni Karukkadai (300)  63. 
64. 
58.  Bhogar (700) 
65. 
59.  Pulippani (500) 
66. 
60.  Agasthiyar Paripuranam (400) 

Therayar Yamagam 
Agasthiyar Chenduram (300) 
Agasthiyar (1500) 
Athmarakshamrutham 
Agasthiyar Pin (80) 
Agasthiyar Rathna Churukkam 

1. Subs. by Act 13 of 1964, s. 31, for the Schedule, the First Schedule came into force (w.e.f. 1-2-1969) and the Second 

Schedule came into force (w.e.f. 15-9-1964). 

2. Subs. by Act 68 of 1982, s. 41, for the heading “A-AYURVEDIC (INCLUDING SIDDHA) SYSTEM” (w.e.f. 1-2-1983). 
3. Ins. by G.S.R. 337(E), dated 15-4-2010.   
4. Ins. by G.S.R. 735 (E), dated 28-8-1987. 
5. Subs by G.S.R. 337 (E), dated 15-4-2010. 
6. Ins. by G.S.R. 423 (E), dated 11-6-2002. 

39 

 
 
 
 
 
 
 
 
 
 
                                                           
SI. No.          Name of book 

SI. No.           Name of book 

67.  Therayar Karisal (300) 
68.  Veeramamuni Nasa Kandam 
69.  Agasthiyar (600) 
70.  Agasthiyar Kanma Soothiram 
71.  18 Siddhar's Chillarai Kovai 
72.  Yogi Vatha Kaviyam 
73.  Therayar Tharu 
74.  Agasthiyar Vaidya Kaviyam (1500) 

75.  Bala Vagadam 

76.  Chimittu Rathna (Rathna) 

Churukkam 
77.  Nagamuni (200) 
78.  Agasthiyar Chillarai Kovai 
79.  Chikicha Rathna Deepam 
80.  Agasthiyar Nayana Viahi 
81.  Yugi Karisal (151) 
82.  Agasthiyar Vallathi (600) 

83.  Therayar Thaila Varkam 

 3[B.—UNANI TIBB SYSTEM] 

1.  Karabadin Qadri 
2.  Karabadin Kabir 
3.  Karabadin Azam 
4.  Ilaj-ul-Amraz 
5.  Al Karabadin 
6.  Biaz Kabir Vol. II 

1[84.  Siddha Formulary of Unani Medicine  

  (Part I)] 

2[85.  Siddha Pharmacopoeia of India and  

its Parts.] 

7.  Karabadin Jadid 
8.  Kitab-ul-Taklis 
9.  Sanat-ul-Taklis 
10.  Mifta-ul-Khazain 
11.  Madan-ul-Aksir 
12.  Makhzan-ul-Murabhat 
 1[13.  National Formulary of Unani Medicine 

  4[***] 

      5[14. Unani Pharmacopoeia of India] 

1. Added by G.S.R. 735 (E), dated 28-8-1987.  
2. Ins. by G.S.R. 337 (E), dated 15-4-2010.   
3. Subs. by Act 68 of 1982, s. 41, for the heading “B-UNANI (TIBB) SYSTEM” (w.e.f. 1-2-1983). 
4. The brackets, word and figure “(Part I)” Omitted by G.S.R. 72 (E), dated 31-1-2003. 
5. Ins. ibid. 

40 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
THE SECOND SCHEDULE  

(See sections 8 and 16) 

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS 
MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE OR 
DISTRIBUTED 

                  Class of drug 

Standard to be complied with 

1.    Patent or proprietary medicines 1[other than         

Homoeopathic medicines]. 

2[2.  Substances  commonly  known  as 
vaccine,  seratoxines, 
toxoids,  anti -
toxins  and  antigens  and  biological 
products like nature, for human use or 
for veterinary use.  

the 

The formula or list of ingredients displayed in 
the  prescribed  manner  on 
label  or 
container  and  such  other  standards  as  may  be 
prescribed. 
the  Inter-
The  standards  maintained  at 
national  Laboratory  for  Biological  Stan-
dards, Stantans Serum Institute, Copenhagen 
and  at  the  Central  Veterinary  Laboratory, 
Way  bridge  Surrey,  U.  K.,  and  such  other 
laboratories  recognised by  the  World  Health 
Organisation  from  time  to  time,  and  such 
further  standards  of  strength,  quality,  and 
purity, as may be prescribed.] 

3[*                                      *                                        *                                 *                                   * 
4.  Substances  (other  than  food)  intended                                    

Such standards as may be prescribed.  

to  affect  the  structure  or  any  function       
of  the  human  body  or  intended  to  be 
used  for  the  destruction  of  vermin  or 
insects  which  cause  disease  in  human 
beings or animals. 

4[4A. Homoeopathic Medicines:  

(a) Drugs included in the Homoeopathic  

Pharmacopoeia of India.  

(b)  Drugs  not  included  in  the  Homoeo -
pathic  Pharmacopoeia  of  India  but 
which  are  included  in  the  Homoeo -
pathic  Pharmacopoeia  of  United 
States  of  America  or  the  United 
Kingdom 
German 
or 
Homoeopathic Pharmacopoeia. 
(c)  Drugs  not  included  in  the  Homoeo-
pathic  Pharmacopoeia  of  India  or  the 
United  States  of  America,  or  the 
United  Kingdom  or 
the  German 
Homoeopathic Pharmacopoeia. 

the 

5[5.   Other drugs :  

(a)  Drugs included in the Indian 

Pharmacopoeia. 

Standards  of  identity,  purity  and  strength 
specified  in  the  edition  of  the  Homoeo -
pathic  Pharmacopoeia  of  India  for  the  time 
being  and  such  other  standards  as  may  be 
prescribed. 
Standards  of  identity,  purity  and  strength 
prescribed  for  the  drugs  in  the  edition  of 
such  Pharmacopoeia  for  the  time  being  in 
which  they  are  given  and  such  other  stan -
dards as may be prescribed. 

The  formula  or  list  of  ingredients  displayed 
in  the prescribed  manner on  the label of  the 
container  and  such  other  standards  as  may 
be prescribed by the Central Government.] 

Standards  of  identity,  purity  and  strength 
specified  in  the  edition  of  the  Indian  Phar -
macopoeia for the time being and such othe r 
standards as may be prescribed. 

1. Ins. by notification No. S.O. 887, dated 19th March, 1966, Gazette of India, Pt. II, s. 3 (ii), p. 819.  
2. Subs. by notification No. G.S.R. 299 (E), dated 23-4-1984. 
3. Omitted, ibid. 
4. Subs. by notification No. S.O. 820, dated the 6th June, 1978, Gazette of India, 1978, Pt. II, s. 3 (ii), p. 1471. 
5. Subs. by notification No. S.O. 885, dated 4th August, 1973, Gazette of India, 1973, Pt. II, s. 3 (ii), p. 1643. 

41 

 
 
 
 
 
                                                           
 
            Class of drug 

                                             Standard to be complied with 

(b)  Drugs  not  included  in  the  Indian  Phar-
macopoeia but which are included in the 
official  Pharmacopoeia  of  any  other 
country. 

In  case  the  standards  of  identity,  purity  and 
strength  for  drugs  are  not  specified  in  the 
edition  of  the  Indian  Pharmacopoeia  for  the 
time  being  in  force  but  are  specified  in  the 
Indian  Pharmacopoeia 
edition 
of 
immeiately  preceding, 
the  standards  of 
identity,  purity  and  strength  shall  be  those 
occurring  in  such  immediately  preceding 
edition  of  the  Indian  Pharmacopoeia  and 
such other standards as may be prescribed. 

the 

Standards  of  identity,  purity  and  strength 
specified  for  drugs  in  the  edition  of  such 
official  Pharmacopoeia  of  any  other  country 
for  the  time  being  in  force  and  such  other 
standards as may be prescribed. 

In  case  the  standards  of  identity,  purity  and 
strength  for  drugs  are  not  specified  in  the 
edition of such official Pharmacopoeia for the 
time  being  in  force  but  are  specified  in  the 
edition  immediately  preceding  the  standards 
of  identity,  purity  and  strength  shall  be  those 
occurring 
immediately  preceding 
edition  of  such  official  Pharmacopoeia  and 
such other standards as may be prescribed.]]  

in  such 

42 

 
 
 
 
 
 
 
